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Subpart 360-17:Regulated Medical Waste Treatment Facilities

(Statutory authority: Environmental Conservation Law, Sections 1-0101, 3-0301, 8-0113,19-0301, 19-0306, 23-2305, 23-2307, 27-0101, 27-0106, 27-0107, 27-0109, 27-0305, 27-0703, 27-0704, 27-0705, 27-0911, 27-1317, 27-1515, 52-0107, 52-0505, and 70-0107)

[Effective Date December 31, 1988]

[Amendment Dates:
Revised Effective March 27, 1990; with promulgation of new Subpart 15: Grants for Comprehensive Solid Waste Management Planning.
Revised Effective May 28, 1991; With repeal of existing Subpart 9 and promulgation of new Subpart 9: State Assistance for Municipal Landfill Closure Projects
Revised Effective January 25, 1992; With repeal of existing Subpart 10 and promulgation of new Subpart10: Regulated Medical Waste Storage, Transfer, and Disposal, and new Subpart 17 Regulated Medical Waste Treatment Facilities.
Revised/Enhanced Effective October 9, 1993; with adoption of amendments to existing Subparts 1 through 17
Revised Effective December 14, 1994; with adoption of amendments to existing Subpart 9: State Assistance for Municipal Landfill Closure Projects
Revised Effective January 14, 1995; With repeal of existing Subpart 14 and promulgation of new Subpart 14: Used Oil.
Revised Effective November 26, 1996; With adoption of amendments to existing Subparts 1, 2, 3, 7, 11, 14, and 17

Revised Effective September 29, 1997; With adoption of amendments to existing Subpart 9
Revised Effective November 21, 1998; With adoption of amendments to existing Subpart 2
Revised Effective November 24, 1999; With adoption of amendments to existing Subparts 2, 3, 4, 5, 9, 11, 14, and 16]

[This is page 1 of 1 of this Subpart. A complete list of Subparts in this regulation appears in the Chapter 4 contents page. A list of sections in this subpart appears below.]

Contents:

Sec.

§360-17.1 Applicability.

(a) Applicability. This Subpart regulates the construction and operation of facilities which treat and destroy regulated medical waste (RMW), except as provided in subdivision 360-17.1(c) of this section. In addition, RMW treatment facilities must comply with the applicable provisions of Subpart 360-1 of this Part. Regulations governing construction and operation of RMW treatment facilities requiring an air pollution control permit are set forth in Parts 200, 201, 211, 212, 219 and 257 of this Title. Regulations governing the tracking and management of RMW are set forth in Part 364 of this Title. Regulations governing the disposal of RMW and the construction and operation of facilities which store and transfer RMW are set forth in Subpart 360-10 of this Part. This Part does not apply to the decontamination of reusable equipment unless a waste is generated. If such waste is a RMW and the RMW is treated at the facility by a treatment unit, this Part applies to such treatment facility. RMW must be managed in accordance with Subparts 360-17 and 360-10 of this Part and Part 364 of this Title until it has been both treated and destroyed, after which it can be managed as a commercial solid waste.

(b) Approved treatment methods. RMW may be treated by the following methods:

(1) combustion in an incinerator regulated under Parts 200, 201, 211, 212, 219, and 257 of this Title and, if applicable, Subparts 360-1 and 360-3 and subdivision 360-17.3(g) of this Part, except for hazardous waste identified or listed in Part 371 of this Title or radioactive materials or NARM waste as defined in Parts 380, 382 and 383 of this Title or low-level radioactive waste that is required by Parts 380, 382 and 383 of this Title to be disposed of at a Part 383 permitted facility;

(2) autoclaving, except for recognizable human body parts, recognizable animal carcasses and body parts, hazardous waste identified or listed in Part 371 of this Title, chemotherapeutical waste, antineoplastic waste, pathological wastes, bulk liquids, and radioactive materials or NARM waste as defined in Parts 380, 382 and 383 of this Title or low-level radioactive waste that is required by Parts 380, 382 and 383 of this Title to be disposed of at a Part 383 permitted facility;

(3) discharge to a sewage system if the waste is liquid or semi-liquid, except as prohibited by the New York State Department of Health, local laws, or ordinances; or

(4) other treatment methods approved in writing by the commissioner of the New York State Department of Health. The procedures required to receive New York State Department of Health approval for any other treatment method are found at 10 NYCRR subdivision 70-1.4(d). In addition, the proposer or applicant must submit a detailed and thorough written proposal to the individuals identified in subdivision 360-17.4(e) of this Part, for environmental review, that provides specifics of the treatment method proposed. This proposal must include:

(i) experience with existing equipment operations and include contact names, addresses, and telephone numbers;

(ii) testing and supporting documentation conducted on pilot or test scale projects or actual operating equipment; and

(iii) sufficient information to determine the efficacy of the proposed treatment technology, including its ability to completely and consistently kill the appropriate biological indicator for the technology chosen.

(5) radioactive materials or NARM waste as defined in Parts 380, 382 and 383 of this Title or low-level radioactive waste that is required by Parts 380, 382 and 383 of this Title to be disposed of at a Part 383 permitted facility may not be treated at a solid waste management facility subject to this Part unless that facility has been issued a permit pursuant to Part 380 of this Title.

(c) Exemption. RMW treatment facilities and destruction processes located on-site of, and operated by, a health care facility licensed pursuant to Public Health Law article 28, and clinical laboratories licensed pursuant to Public Health Law section 571 are exempt from this Part for the treatment and destruction of RMW generated from that facility or laboratory. Such exempt facilities may accept RMW from other generators of RMW provided they first obtain written agreements with each such generator and submit copies of these agreements to the department and the New York State Department of Health.

(d) Existing facilities. RMW treatment facilities which have chosen to treat RMW, but then send this RMW to a department-approved treatment facility for treatment, and package, label, and transport such RMW as if it had not been treated, are not subject to this Subpart. If such RMW treatment facilities propose to treat RMW in accordance with the requirement of this Subpart, then the owner or operator of such RMW treatment facility must immediately comply with the operating requirements of sections 360-17.4 and 360-17.5 of this Part. In addition, such owner or operator must submit a complete application for a permit to construct and operate the existing RMW treatment facility in accordance with section 360-17.3 of this Part before RMW will be considered properly treated. A draft validation testing program, draft procedures for developing the standardized load, and draft procedures for conducting and analyzing the results of challenge testing, prepared in accordance with sections 360-17.3 and 360-17.5 of this Part, must also be submitted as part of the permit application. No RMW will be considered properly treated until the results of the validation testing program have been approved in writing by the New York State Department of Health.

(e) New York State Department of Health approvals. Whenever approval is required by Subpart 360-17 of this Part in writing from the New York State Department of Health, two copies of the required documents must be submitted by the applicant to the director, Division of Solid Waste, New York State Department of Environmental Conservation, 50 Wolf Road, Albany, New York 12233-4010. The director will coordinate the review and approval of these documents within the department and with the New York State Department of Health. The applicant shall also submit two copies of the required documents to the regional permit administrator in the departmental region in which the facility is located. The applicant will be notified in writing by the regional permit administrator of the results of the review. Reference to New York State Department of Health may be found in sections 360-17.1(b)(4), 360-17.1(d), 360-17.2(c), 360-17.3(d), 360-17.3(g)(2), 360-17.4(b)(9), 360-17.5(a)(4), 360-17.5(b)(1), 360-17.5(b)(2), 360-17.5(b)(c)(2), and 360-17.5(d) of this Subpart.

§360-17.2 Definitions.

For the purposes of this Subpart, the definitions contained in Subpart 360-1 of this Part and Section 364.9 of this Title apply. In addition, the following definitions apply:

(a) Autoclave means a vessel using saturated steam under pressure to treat RMW.

(b) Bypass RMW means RMW which constitutes bypass waste as defined by subdivision 360-1.2(b) of this Part.

(c) Challenge testing means tests of each treatment unit with a biological indicator approved by the New York State Department of Health to verify the effectiveness of each RMW treatment unit and the RMW treatment process using the standardized load as described in the approved operation plan.

(d) Daily start-up means the powering up of each RMW treatment unit and its appurtenances. For intermittent unit operation, multiple daily start-ups could occur.

(e) Destroyed RMW means RMW that has been ruined, torn apart, or mutilated through processes such as thermal treatment, melting, shredding, grinding, tearing or breaking, so that it is no longer generally recognizable as RMW. It does not mean compaction.

(f) Infectious agent means any organism (such as a virus or a bacterium) that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans.

(g) Operating parameters means the time, temperature, pressure and other operating conditions maintained to effect treatment of RMW.

(h) Regulated medical waste.

(1) A regulated medical waste is any medical waste that is a solid waste, as defined in subdivision 360-1.2(a) of this Part, generated in the diagnosis, treatment (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, that is not excluded or exempted under subparagraph 360-17.2(h)(2) of this paragraph, and that is listed below:

(i) cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures;

(ii) human pathological wastes, including tissues, organs, body parts and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers;

(iii) liquid waste human blood, products of human blood, items saturated and/or dripping with human blood, or items that were saturated and/or dripping with human blood that are now caked with dried human blood, including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags are also included in this category;

(iv) sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic needles, syringes (with or without the attached needle), pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips;

(v) contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals;

(vi) wastes from surgery or autopsy that were in contact with infectious agents, including soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves;

(vii) laboratory wastes from medical, pathological, pharmaceutical, or other research, commercial, or industrial laboratories that were in contact with infectious agents, including slides and cover slips, disposable gloves, laboratory coats, and aprons;

(viii) dialysis wastes that were in contact with the blood of patients undergoing hemodialysis or renal dialysis, including contaminated disposable equipment and supplies such as tubing, filters, disposable sheets, towels, gloves, aprons, and laboratory coats;

(ix) biological waste and discarded materials contaminated with blood, excretion, exudates, or secretion from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases; and

(x) the following unused, discarded sharps: hypodermic needles, suture needles, syringes, and scalpel blades.

(2) Exclusions and exemptions.

(i) Exclusions.

(a) hazardous waste identified or listed under the regulations in Part 371 of this Title is not RMW;

(b) household waste, as defined in this Part, is not RMW;

(c) ash from incineration of RMW is not RMW once the incineration process has been completed;

(d) residues from treatment and destruction processes are no longer RMW once the waste has been both treated and destroyed; and,

(e) human corpses, remains, and anatomical parts that are intended for interment or cremation are not RMW.

(ii) Exemptions.

(a) Samples of RMW transported off-site by EPA or State-designated enforcement personnel for enforcement purposes are exempt from the requirements of this Part during the enforcement proceeding;

(b) RMW that has been decontaminated by autoclaving, or by other technique approved by the Department of Health. RMW so treated shall be disposed of as solid waste provided it is not otherwise a hazardous waste as defined in ECL section 27-0903 or the regulations promulgated thereunder, is accompanied by a certificate, in a form prescribed by the Commissioner of Health which evidences such treatment, and complies with the requirements of ECL section 27-1507, and the Public Health Law sections 1389-dd and 3381-a.

(i) Residence time means the duration of time which begins when the minimum operating parameters as established by validation testing have been attained and continues for the length of time established by validation testing for the effective treatment of RMW.

(j) Standardized load means a specific quantity and configuration of RMW representative of the type of RMW to undergo treatment which has been established by the facility's approved operation plan.

(k) Treated RMW means RMW that has been treated to substantially reduce or eliminate its potential for causing disease but has not yet been destroyed.

(l) Treatment means any method, technique, or process designed to change the character or composition of any RMW so as to either neutralize such waste or to render such waste not infectious, safer for transport, amenable for recovery, amenable for storage, or reduced in volume.

(m) Treatment facility means, for the purposes of this Subpart, a solid waste management facility that either provides treatment or destruction of RMW.

(n) Untreatable waste means, for the purposes of this Subpart, RMW which cannot undergo treatment using the technology chosen. Untreatable wastes for specific technologies are described in subdivision 360-17.1(b) of this Part.

(o) Validation testing means the procedures, established by the validation testing program prior to commercial operation, used to verify the efficacy of each RMW treatment unit and the RMW treatment process.

§360-17.3 Application requirements for a permit to construct and operate.

In addition to the applicable provisions of Subpart 360-1 of this Part, except for the requirements of subdivisions 360-1.9(f) and 360-1.11(h) of this Part, an application for an initial permit to construct and operate a RMW treatment facility (which, for the purposes of this Subpart, includes start-up and validation testing) must contain draft facility plans. These facility plans include: an operation plan; a maintenance and monitoring plan; a personnel staffing and training plan; a waste control plan; a contingency plan; a closure plan; and a security plan. The contents of these facility plans are described in subdivisions 360-17.3(g)-(m) of this section. Final facility plans must be submitted to the department for review and written approval prior to commercial operation. Subdivisions 360-17.3(a)-(m) must be included in an application for an initial permit to construct and operate. An application for a renewal of the initial permit to construct and operate or permit to operate must contain revised facility plans as described in subdivision 360-17.3(g)-(m).

(a) Engineering report. The engineering report must include the following:

(1) a general description of the overall process and functional description of all equipment to be used, with design criteria, and anticipated performance and process flow diagrams;

(2) a description of the proposed service area, including generic sources and quantities of RMW anticipated;

(3) identification of sufficient support equipment to maintain operation of all treatment and destruction equipment functions;

(4) a description of the facility operation which includes:

(i) a sequential description of the major components used for the treatment of the RMW, including storage, weighing, processing, treatment and destruction;

(ii) a description of operations for initial facility start-up, daily start-up, and scheduled and unscheduled shutdowns;

(iii) a description of the appropriate operating parameters for the proposed facility, such as residence time, temperature, pressure, irradiation levels and chlorine concentrations;

(iv) a description of the methods and equipment to disinfect reusable containers, if provided;

(v) a description of facility usage, including days and hours of operation, and number of treatment units; and

(vi) in addition to the requirements of subdivisions 360-1.14(k)-(m) of this Part, a description of the proposed methods to control the emission of odors, volatile organic compounds, or other contaminants generated by the facility operations (e.g., negative building air pressure, fans and vents, internal air recirculation, air pollution control equipment and filtration), as necessary to comply with subdivision 360-17.4(f) of this Subpart, including all supporting design and engineering data;

(5) a description of the RMW proposed to be treated, processed, or destroyed for the initial year, and yearly projections for a minimum of 10 years or the life of the facility, whichever is less, in terms of:

(i) Quantity. Submit a table or graph showing the projected quantities delivered per month during the first year of operation and the background data and assumptions used to produce this table or graph. Describe all RMW materials, anticipated variations in quantity received and projections for future quantities of RMW to be treated, processed, stored or destroyed; and

(ii) RMW characteristics. Estimates, along with assumptions and supporting data, of the RMW characteristics such as: density (peak and low), composition, moisture content, rate of steam penetration of the RMW, and RMW packaging and containers to be treated;

(6) a summary of the utility requirements, including:

(i) an estimate of the type, quantity, and on-site storage of fuels needed for the facility;

(ii) estimates of steam generated and utilized on-site in terms of pressure, temperature, and pounds per hour;

(iii) estimates of water used for cooling, sanitary and process water, including that which is, or may be, recycled or treated; and

(iv) characterization and estimates of domestic sewage, process water, storm water run-off and drainage, and a description of disposal, including point of discharge;

(7) a list and description of all authorizations, permits, and approvals that may be required for this facility, including those from the department, other state agencies, federal agencies, local governments, sewer districts, the Adirondack Park Agency, and agricultural districts;

(8) a description of the provisions necessary to enable emergency shutdown of the facility;

(9) a complete description of the RMW handling and storage methods, in accordance with Part 364 of this Title, which are used during facility operation. Also, this description shall include the proposed methods to handle bypass RMW, untreatable waste, and unauthorized waste for the technology chosen; and

(10) a brief description of provisions for transportation of RMW to and from the facility, and for any subsequent processing, storage, treatment, destruction, and ultimate disposal.

(b) Engineering plans and specifications. In addition to the requirements of subdivision 360-1.9(e) of this Part, the following is required:

(1) Engineering plans that contain information on known site conditions and projected site use. The engineering plans must show general dimensions of the proposed structures and be sufficiently detailed to identify the overall process, as follows:

(i) a site plan which shows the following within 1,000 feet of the proposed facility site: the facility's property boundaries; site acreage; distances from adjacent residences, property owners and population centers; off-site and on-site utilities, such as electric, gas, water, storm, and sanitary sewer systems; a north arrow; site topography; the location of screening, regulated wetlands, rights-of-way, surface water conditions, floodplains, buildings, and appurtenances, fences, gates, roads, staging areas, parking areas, drainage culverts, and signs; location of soil borings, if available; transportation systems in the vicinity of the facility including, highways, airports, railways, and ports; the location and identification of handling and storage areas for RMW, untreatable waste, and unauthorized waste not located in the primary building; and a wind rose;

(ii) preliminary piping and instrumentation diagrams;

(iii) plan and cross-section views of the facility taken at different elevations in the facility, which must include: the storage areas for RMW, and any temporary storage areas for bypass RMW, unauthorized waste, and untreatable waste, intended equipment locations, anticipated equipment configurations, air supply ductwork locations, on-site utilities, and anticipated underdrain locations (as appropriate); and

(iv) plans of the facility operation that contain a process flow diagram or diagrams to illustrate the complete material and process sequence. They must depict all major equipment associated with the facility, including weighing, processing, heating, cooling, ventilation, radiation detection, treatment, destruction, and storage of all RMW and solid waste;

(2) performance specifications for all major equipment, instrumentation and control centers incorporated into the facility; and

(3) project construction schedules which incorporate specific information essential for monitoring the progress of the project. Bar chart schedules are acceptable, if they indicate the individual time spans from start to completion. Time requirements must be shown for design and engineering, construction milestone dates, equipment deliveries, and the start and completion date for construction. Critical path scheduling may be used in lieu of bar chart schedules. After the permit to construct and operate is issued, monthly updates of project construction activities must be submitted in accordance with the procedures described in subdivision 360-17.4(e) of this Subpart.

(c) Treatment, destruction and disposal facility. The following information must be provided:

(1) the name and mailing address of the treatment, destruction, and disposal facility or facilities that will receive all solid waste removed from the facility (i.e. treated, untreated, and bypass RMW; untreatable and unauthorized wastes; and treated and destroyed medical waste), including the name, title, mailing address, and telephone number of the individual who is the facility contact. Each such treatment, destruction or disposal facility must:

(i) if located in New York State, be currently authorized to operate or have an application deemed complete by the department or other appropriate regulatory agency, and be capable of demonstrating a projected capacity to accept the projected solid waste for two years from the anticipated operation start date of the proposed RMW treatment facility. Disposal facilities must be approved by the department to accept treated RMW, and treated and destroyed medical waste in accordance with section 360-10.5 of this Part; and

(ii) if located outside of New York State, also submit a copy of authorization to operate (i.e. permit to operate) certified by the appropriate regulatory agency of that state or country, including the agency contact person's name, address and telephone number; and

(2) 90 days before start-up, one original and one copy of an executed agreement with the facility or facilities that will receive the projected solid waste for a minimum of two years. Include the name, mailing address, telephone number and New York State permit number of each transporter permitted under Part 364 of this Title that is proposed for shipment off-site to the designated treatment, destruction or disposal facility.

(d) Validation testing program. A description of the proposed validation testing program, which complies with the requirements of subdivision 360-17.5(b) of this Part, must be submitted to the department. The results of validation testing will be used to establish facility operating parameters, and these parameters will be included as special conditions in the permit. Operation of the facility beyond start-up and validation testing will not be permitted until the results of the validation testing program have been approved, in writing, by the New York State Department of Health.

(e) Surety. The applicant must provide proof of liability insurance or other form of financial surety deemed sufficient by the department, in an amount of at least $1,000,000, to meet all responsibilities in case of release of RMW causing bodily injury or property damage, including liability for environmental restoration resulting from negligence in operation.

(f) Facility plans. All facility plans shall be submitted for department review as follows:

(1) final facility plans must be submitted to the department for review not less than 90 days before any RMW is received by the facility;

(2) final facility plans must be approved, in writing, by the department before any RMW is received at the facility;

(3) updated facility plans must be submitted to the department for review with each renewal application; and

(4) any proposed substantial changes to any of the elements of the department-approved facility plans required by this Part must be submitted to the department in accordance with the procedures described in subdivisions 360-1.8(e) and 360-17.4(e) of this Part for review and approval before these changes are implemented.

(g) Operation plan. The operation plan shall establish facility operating procedures, describe the management of RMW within the facility, and minimize bypass RMW.

(1) The operation plan must include the following:

(i) a description of the proposed procedures for the operation of each major facility component;

(ii) procedures to be followed during daily start-up and scheduled and unscheduled shutdown of operations;

(iii) a description of the measures proposed to control dust, noise, litter, odors, vectors, and blowing debris at the facility;

(iv) an inventory and location of all facility records and as-built construction drawings;

(v) a list of chemicals, including quantities to be used at the facility, amounts to be stored, location of storage, and safety procedures for handling and storage, as appropriate;

(vi) a description of the daily operating procedures for RMW treatment facilities in accordance with the requirements of sections 360-17.4 and 360-17.5 of this Subpart;

(vii) a description of the measures proposed for radioactive waste detection;

(viii) a description of proposed storage methods, including provisions for storage beyond 48 hours; and

(ix) other items as identified by the department that are specific to the individual facility due to its location, technology, or type of RMW delivered (such as processing, storage, and handling).

(2) The department and the New York State Department of Health will review the proposed operation plan for consistency with the following requirements for the handling, storage, treatment, and disposal of RMW:

(i) a method of receiving RMW that ensures that RMW is handled separately from other solid waste until treatment and destruction, or treatment and disposal, and that prevents unauthorized persons from having access to, or contact with, the RMW;

(ii) a method of unloading and processing RMW that limits the number of persons handling RMW and minimizes the possibility of RMW exposure to employees and the public using or visiting the facility. Except for reusable containers, RMW containers for the management of untreated RMW shall not be opened, unless such a procedure is part of the approved treatment process;

(iii) a method of processing, disinfecting, and treating emptied reusable RMW containers, transport vehicles, and facility equipment;

(iv) required use of protective clothing, such as gloves and clean uniforms, to provide protection of employees against exposure to RMW;

(v) the means of decontaminating any person having had bodily contact with RMW while handling or treating the RMW at the site;

(vi) a quantification, on a weight basis, of the maximum amount of RMW to be treated, stored, or removed from the facility each day;

(vii) appropriate methods for handling and processing RMW with packaging that is leaking, dented, ripped, torn or bulging;

(viii) the procedures for conducting the challenge testing and analyzing the results;

(ix) the procedures for establishing the standardized load; and

(x) the procedures for conducting the validation testing program and analyzing the results.

(3) Whenever there is a proposed increase in the permitted design capacity of the treatment facility, or when changes are otherwise made in an existing operation plan, two copies of a new or revised operation plan shall be submitted to the department in accordance with the provisions of subdivisions 360-1.8(e) and 360-17.4(e) of this Part for review and approval before the proposed increase or change is implemented.

(4) The department may withdraw approval for acceptance of RMW at a treatment facility for noncompliance with the approved operation plan. The permittee may request a hearing after such withdrawal in accordance with ECL section 27-1517.3 or Subpart 621.14 of this Title.

(h) Maintenance and monitoring plan. In addition to the requirements of subdivision 360-1.4(f) of this Part, the maintenance and monitoring plan that is submitted must:

(1) include an analysis of spare parts needed to keep the facility operational; an analysis of parts that are expected to frequently fail; and suggested list of spare parts and quantity of each that will be maintained as inventory. This list must be as detailed as necessary to allow an inventory check to be accomplished. The method of recording spare parts usage and inventory control also must be identified. The facility must maintain an adequate supply of spare parts necessary to keep the facility operational;

(2) describe the monitoring and inspections to be undertaken at the facility to discover and correct equipment malfunctions or deteriorations, operator errors, and discharges that may threaten the environment or human health;

(3) provide a schedule for the inspection and repair of equipment at the facility including safety, emergency, and security equipment which is necessary to ensure optimization of equipment availability. The frequency of inspection must be based on the projected rate of equipment deterioration or malfunction and the probability of failure between inspections. In addition, a detailed visual inspection of each treatment unit and its associated equipment shall be conducted every 40 hours of operation in conjunction with challenge testing. Areas of the facility subject to spills and areas in which adverse environmental or health consequences may result if breakdown occurs, must be inspected daily;

(4) identify the operating parameters for the process and any control devices used to detect a malfunction or failure, the normal range of these variables, and describe the method of monitoring and the sequence of responsible action in the event that the equipment and instruments deviate from normal operating ranges;

(5) describe methods and schedules to check operation of control equipment and instrumentation, including a list of all equipment and instruments requiring calibration and a schedule of proposed calibration intervals. All process instruments shall be calibrated at least annually. Process control instruments shall be maintained in proper operating condition at all times; and

(6) include requirements for a general facility inspection, conducted at least annually, of the items described in paragraph 360-17.3(h)(3) of this Part, to ensure that the facility is operating in accordance with the approved facility plans. This annual facility inspection must be performed under the direction of an individual licensed to practice engineering in the State of New York. The individual must prepare a summary report of the findings resulting from this inspection. The annual facility inspection report must be signed and embossed with the individual's engineering seal. The annual facility report must be submitted in accordance with the provisions of subdivision 360-17.4(e) of this Subpart.

(i) Personnel staffing and training plan. The personnel staffing and training plan that is submitted must:

(1) demonstrate that adequate staff are provided for essential positions and describe how all facility personnel will successfully complete a program of instruction, on-the-job training, and periodic retraining. This training must teach staff to perform their duties in a way that ensures the facility's compliance with the requirements of this Part and Part 364 of this Title;

(2) identify facility personnel and the procedures that will be used to train facility staff in the processing and handling of all solid waste received at the facility in accordance with the waste control plan of subdivision 360-17.3(j) of this section;

(3) identify the positions which will receive training, and identify the instructor(s) who must know the procedures, equipment, and processes at the facility. The training must teach facility personnel proper RMW management procedures (including contingency plan implementation) relevant to the positions in which they are employed. This training and staffing plan must include, where applicable:

(i) procedures for familiarizing facility personnel with emergency equipment, radiation detection devices and safety equipment, emergency procedures, and emergency systems;

(ii) procedures for using, inspecting, repairing, and replacing facility emergency and monitoring equipment;

(iii) key parameters for system shutoff;

(iv) communication or alarm systems;

(v) response to fires or explosions, spills, and leaks;

(vi) response to surface and groundwater contamination incidents; and

(vii) start-up and shutdown of operations;

(4) show how facility personnel will complete the personnel training requirements of this subdivision within three months of the date of their employment or assignment to a facility. Each employee must complete personnel safety training concerning the handling and management of RMW and worker protection prior to being exposed to RMW. Employees must not work in unsupervised positions until they have completed the training requirements of this subdivision;

(5) show how facility personnel will participate in an annual evaluation of the training required in this subdivision. The results of this evaluation will be included in the annual report required by paragraph 360-17.4(e)(3) of this Subpart;

(6) include examples of the following records which must be maintained at the facility:

(i) the job title for each position at the facility related to RMW management, the name of the employee filling each job, and a written job description for each position. This description must include the requisite skills, education, or other qualifications and duties of employees assigned to each position;

(ii) a written description of the type and amount of both introductory and continuing training that will be given to each person filling a position listed under subparagraph 360-17.3(i)(6)(i) of this paragraph; and

(iii) documentation that the training has been given to, and completed by, facility personnel;

(7) provide for the maintenance of training records for current and former employees of the facility in accordance with subdivision 360-1.14(j) of this Part; and

(8) provide that the on-site operation of any RMW treatment facility subject to these requirements is directed at all times by a person(s) possessing an appropriate current New York State RMW Treatment Facility Operation Certification. (This paragraph is effective nine months after the date of the first qualifying examination approved by the commissioner.)

(j) Waste control plan. In addition to addressing the requirements of subdivision 360-1.14(f) of this Part and subdivision 364.9(h) of this Title, the waste control plan that is submitted must:

(1) ensure that the facility receives, stores, treats, and destroys only RMW specifically authorized by the department;

(2) provide a notification program to instruct all generators and transporters who will use the facility of the types of RMW which are authorized to be accepted at the facility. Also, the notification program must identify those wastes which are untreatable and unauthorized at the facility, including radioactive wastes. This notification program must include one or more of the following:

(i) training programs for the generators and transporters; or

(ii) contractual requirements with generators or transporters that contain specific provisions to prevent untreatable and unauthorized wastes from being received at the facility; or

(iii) a solicitation letter and questionnaire that must be mailed to all known generators and transporters whose RMW will be sent to the facility, requesting the name of their RMW transporters, a description of the RMW proposed for treatment, and the names of any chemical used or wastes generated that may potentially be delivered to the proposed facility, and a copy of the operating procedures which the generator and transporter will use for handling and separating RMW. Implementation of the approved notification program must be undertaken at least 90 days before start-up, and must be undertaken no less frequently than every two years thereafter. Department approval to accept RMW at the facility will not be granted until the department has verified that an approved notification program has been properly implemented. The facility must not accept RMW from any generator or transporter, including generators and transporters contracted with after issuance of the permit to construct and operate, until they have participated in the approved notification program;

(3) ensure the facility will not accept RMW which is not packaged, labeled, and marked in accordance with subdivision 364.9(d) of this Title;

(4) ensure the facility will not accept RMW which is not accompanied by a tracking form that complies with the requirements of paragraph 364.9(e)(3) of this Title; and

(5) provide an on-site program to identify, control, separate out, record, and prevent untreatable and unauthorized wastes from being accepted and treated at the facility. The waste control plan must include a description of how these wastes will be handled and disposed. If these wastes are rejected by the facility, the waste control plan must provide for departmental notification in accordance with subdivision 364.9(h) of this Title. In addition, this program must include the following:

(i) a location for the separation and proper storage of untreatable and unauthorized wastes;

(ii) contractual requirements or other appropriate notification and inspection procedures to remove untreatable and unauthorized wastes from the facility;

(iii) a metal sign, a minimum of 12 inches high by 18 inches wide, that will be conspicuously posted at each entrance to the facility that identifies the types of untreatable and unauthorized wastes which must be separated from the treatable RMW. The information on this sign shall be legible from a distance of at least 25 feet and have lettering a minimum of one inch in height. Procedures for the rejection of untreatable and unauthorized RMW and its separation from treatable RMW must be made available to all RMW transporters;

(iv) daily random inspections of incoming loads before and after treatment;

(v) use of radiation detection devices for radioactivity assessment of all RMW;

(vi) inspections of questionable or unusual loads before or after treatment;

(vii) records of inspections; and

(viii) procedures for identifying and handling untreatable and unauthorized wastes. These procedures must include the following:

(a) separate handling from other RMW received at the facility;

(b) secure wrapping or containerization of such wastes to prevent exposing the contents to personnel or the environment;

(c) provisions to minimize the handling of such wastes;

(d) provisions for storing wastes on-site so that they do not become putrescent;

(e) management of such wastes in accordance with the appropriate portions of the facility plans; and

(f) identification of safety procedures for employees that are required to work with such wastes. Such safety procedures must comply with all applicable OSHA standards, New York State right-to-know and other worker protection laws and requirements.

(k) Contingency plan. The contingency plan that is submitted must:

(1) Provide for the following in addition to the requirements of subdivision 360-1.9(h) of this Part:

(i) a description of the procedures that will be used to minimize hazards to human health and the environment resulting from equipment failure, utility failure (i.e., loss of electricity, water, sewers, etc.), fires, spills, leaks, explosions, or releases into the air, onto the soil, into storm or sanitary sewers, or into groundwater or surface water; and

(ii) a description of the following:

(a) actions facility personnel must take in response to equipment failure, utility failure, fire, explosion, spills, leaks, releases that could threaten human health or the environment, and unscheduled facility shutdown if it exceeds 24 hours;

(b) procedures to follow if operating parameters or associated operating parameter indicator devices do not identify that the minimum operating conditions were achieved during the RMW treatment process in accordance with the approved operation plan;

(c) the personnel safety equipment and protective gear that will be available, including showers, eyewash, fire extinguishers, hoses, hard hats, safety goggles, hearing protection, gloves, full body suits, aprons, absorbants, and proposed personnel hygiene facilities; and

(iii) measures proposed to handle incoming RMW during periods of emergencies, equipment breakdown, or facility shutdown, and methods, such as refrigeration, which will be employed to keep from becoming putrescent;

(2) be maintained at the facility; and a complete copy of the approved contingency plan must be submitted to all local police departments, fire departments, hospitals, State and local emergency response teams that may be called upon to provide emergency services. The emergency coordinator must assure that the provisions of this plan are carried out in the event of an incident covered by the contingency plan;

(3) be immediately amended in accordance with the procedures of subdivisions 360-1.8(e) and 360-17.4(e) of this Part whenever:

(i) the plan fails to adequately address an emergency situation;

(ii) the facility changes in its design, construction, operation, maintenance or other circumstance in a way that materially increases the potential for fires, explosions, spills, leaks, or releases of pollutants or changes the response necessary in an emergency;

(iii) the list of emergency coordinators changes; or

(iv) the list of emergency equipment changes;

(4) provide for the maintenance of adequate aisle space to allow for emergency operations and response by emergency equipment, and provide the following:

(i) an internal communications system capable of providing immediate emergency instruction to facility personnel, or an alarm system to notify facility personnel of an emergency condition;

(ii) a device, such as a telephone (immediately available at the scene of operations) or a hand-held two-way radio, capable of summoning emergency assistance from local police departments, fire departments, and State or local emergency response teams;

(iii) portable fire extinguishers, fire control equipment (including appropriate extinguishing equipment, such as that using foam, inert gas, or dry chemicals), and spill prevention/control equipment; and

(iv) water available in adequate volume and at adequate pressure to supply water hose streams, foam producing equipment, automatic sprinklers, or water spray systems;

(5) describe all equipment that will be tested and maintained to assure its proper operation at all times, including all facility emergency equipment, communications and alarm systems, fire protection equipment, spill prevention/control equipment, and personal safety equipment;

(6) provide for an emergency coordinator and an alternate emergency coordinator as follows:

(i) designate at least one employee at all times during facility operation, either on the facility premises or available to respond to an emergency by reaching the facility within 15 minutes, with the responsibility for coordinating all emergency response measures. This emergency coordinator must be thoroughly familiar with all aspects of the facility's contingency plan, all operations and activities at the facility, the location and characteristics of the RMW managed, the location of all records within the facility, and the facility layout. In addition, this employee must have the authority to commit the personnel, equipment, and financial resources needed to implement the requirements of the contingency plan;

(ii) the emergency coordinator, whenever there is an emergency situation, must immediately ensure that internal facility alarms or communication systems are activated to notify all facility personnel and, if their help is needed, all appropriate State or local agencies with designated response roles;

(iii) if the emergency coordinator determines that the facility has had a major equipment or utility failure, fire, explosion, spill, or leak which could threaten human health or the environment beyond the facility, this finding must be immediately reported by the emergency coordinator to the appropriate officials designated in the contingency plan;

(iv) during an emergency, the emergency coordinator must take all reasonable measures necessary to ensure that fires and explosions, leaks, or spills do not occur, recur, spread into other areas of the facility, or beyond the facility in accordance with the requirements of the contingency plan. These measures must include, when appropriate, stopping equipment and operations, collecting and containing RMW, and removing or isolating RMW containers;

(v) if facility operations cease in response to a major equipment or utility failure, fire, explosion, spill, or leak, the emergency coordinator must monitor for leaks, pressure buildup, gas generation or ruptures in valves, pipes, or other equipment, wherever appropriate;

(vi) immediately after an emergency, the emergency coordinator must provide or arrange for the appropriate treatment, storage, destruction, or disposal of all RMW, contaminated soil or water, and any other solid waste at the facility resulting from the emergency;

(vii) the emergency coordinator must ensure that cleanup procedures are completed in accordance with the provisions of the contingency plan. Emergency equipment used during emergency operations must be thoroughly cleaned of contaminated materials prior to reuse. The owner or operator must provide written notification to the department in accordance with subdivision 360-17.4(e) of this Part, and to appropriate State and local officials when the facility is to resume operations in the affected areas of the facility; and

(viii) the emergency coordinator must note in the operating record and the quarterly report, the time, date, and details of any incident that requires implementing any provisions of the contingency plan and must submit a written report on the incident. This report must be received within 72 hours by the individuals identified in subdivision 360-17.4(e) of this Part. The incident report must include the following:

(a) the name, address, and telephone number of the operator and the facility;

(b) the date, time, and type of incident (i.e., utility failure, fire, explosion, spill, leak, etc.) and in the case of major equipment failure, a description of the equipment and the name of the manufacturer; (c) the type and quantity of materials involved;

(d) the extent of injuries, if any;

(e) an assessment of actual or potential hazards to human health or the environment (groundwater, surface water or air), where this is applicable;

(f) the date of disposal and the location of the disposal facility for the materials involved;

(g) the procedures or equipment available to prevent a recurrence of the reported event; and

(h) any modifications necessary to the contingency plan.

(l) Closure and financial assurance plans. In addition to the closure requirements of subdivision 360-1.14(w) of this Part, the closure plan must also identify the steps necessary to close the facility. This closure plan may be amended at any time during the active life of the facility with department approval. This closure plan must be amended whenever changes in operating plans or facility design affect the closure plan, or whenever there is a change in the expected closure date. Closure requirements are as follows:

(1) the owner or operator must notify the department, in writing, by certified mail, return receipt requested, at least 180 days before the date the facility is expected to begin closure. This notification must be sent to the individuals identified in subdivision 360-17.4(e) of this Part. No RMW may be received after the scheduled date of closure;

(2) within 30 days after receiving the final quantity of RMW, the owner or operator must remove from the site all solid waste including untreatable and unauthorized wastes, in accordance with the approved closure plan;

(3) the owner or operator must complete closure activities in accordance with the approved closure plan within 180 days after receiving the final quantity of RMW;

(4) when closure is completed, the owner or operator must submit a written report to the individuals identified in subdivision 360-17.4(e) of this Part, certified by an individual licensed to practice engineering in the State of New York and retained by the operator or owner, which states that the facility has been closed in accordance with the approved closure plan; and

(5) the closure plan that is submitted must contain the most recent closure cost estimate for the facility prepared in accordance with section 360-1.12 of this Part and a copy of this documentation required to demonstrate financial assurance under section 360-1.12 of this Part.

(m) Security plan. The security plan that is submitted must:

(1) restrict the presence of and minimize the possibility for, any unauthorized entry onto the facility site and limit contact with any RMW. A description of the security measures must be provided in the security plan and must include a means to control entry at all times through the gates or other entrances to the facility (as by a 24-hour surveillance system which continuously monitors and controls entry, or an artificial or natural barrier). Metal signs, legible from a distance of at least 25 feet, that read "CAUTION - REGULATED MEDICAL WASTE. VISITORS AND UNAUTHORIZED PERSONNEL MUST REPORT TO THE OFFICE" must also be posted at each entrance to the facility and at other locations, in sufficient numbers to be seen from any approach to the facility. These signs shall be at least 12 inches high by 18 inches wide, have lettering a minimum of one inch in height and include the nationally recognized bio-hazard symbol; and

(2) identify specific operating areas within the facility where access must be controlled, and the specific control procedures that will be followed.

§360-17.4 Operational requirements.

RMW treatment facilities subject to this Subpart must operate in compliance with the following requirements:

(a) General. All activities at the facility must be performed in accordance with the facility plans and programs required by this Part and approved by the department. These facility plans and programs must be maintained and at all times be available for reference and inspection at the facility.

(b) Receipt and handling of solid waste. All solid waste must be managed in accordance with the following procedures:

(1) only solid waste authorized by the department may be received at the facility. All solid waste received at the facility, and all solid waste which leaves the facility must be weighed and recorded, and the results must be incorporated into the quarterly report;

(2) all RMW received at the facility must be managed in accordance with the requirements of subdivision 364.9(h) of this Title. All solid waste must be completely contained within an enclosed area, in a vehicle, or in another approved device in accordance with the approved operation plan, to minimize the effects of weather, wind, and precipitation. Uncontrolled storage of any solid waste is strictly prohibited. Untreatable or unauthorized wastes may be temporarily stored in areas specifically designed for such wastes on the facility site in accordance with the approved waste control plan;

(3) all solid waste received at the facility that has the ability to become putrescent, or a nuisance, or a sanitary or environmental problem must be stored in the following manner:

(i) for periods of time less than 72 hours after receipt at the facility, solid waste may be stored at room temperature;

(ii) for periods of time from 72 hours to seven days after receipt at the facility, solid waste must be stored in a refrigerated area at a temperature less than 45 F (7 C);

(iii) for periods of time from seven days to 30 days after receipt at the facility, solid waste must be stored in a freezer at a temperature less than 0 F (-18 C); and

(iv) no solid waste may be stored on-site for more than 30 days after receipt at the facility;

(4) any solid waste which becomes putrescent must be immediately treated, refrigerated, frozen, or removed from the facility;

(5) all treated or untreated RMW which leaves the facility shall be transported to an authorized treatment, destruction, or disposal facility by a permitted transporter, packaged and tracked in accordance with section 364.9 of this Title;

(6) all treated and destroyed medical waste that leaves the facility shall be transported directly to the authorized incinerator or disposal facility or facilities identified in subdivision 360-17.3(c) of this Part;

(7) all RMW received at the facility must be transported by permitted transporters in accordance with section 364.9 of this Title or by generators meeting the conditions of paragraph 364.9(e)(2) of this Title;

(8) treated RMW, untreated RMW, treated and destroyed medical waste, and solid waste must not be mixed without written authorization of the department. All post-treatment processing of RMW, and treated and destroyed medical waste, must be conducted in areas separate from treatment and pre-treatment operations to prevent contamination by untreated RMW;

(9) untreated RMW must not be destroyed prior to treatment, unless the destruction process is part of a RMW treatment technology which has been approved in writing by the New York State Department of Health;

(10) mechanical compaction of untreated RMW is strictly prohibited;

(11) except for reusable containers, RMW containers for the management of untreated RMW shall not be opened unless such procedure is part of the approved treatment process;

(12) RMW must be completely protected from the effects of wind, weather, and precipitation during transfer operations. Trash chutes must not be used to transfer RMW between locations. Untreated RMW must not be dumped from one vehicle to another, or from a vehicle to the ground. Untreated RMW must not be handled in a manner that results in the rupturing of RMW packaging or an increase in the risk of exposure to employees or the public;

(13) during the treatment process the minimum approved operating parameters shall be maintained for the entire length of the approved residence time. The residence time will not include any duration of time for which the minimum operating parameters are not achieved; and,

(14) no uncontrolled gases, liquids, or solids may be discharged from the RMW treatment unit before the completion of the treatment cycle.

(c) Drainage. The site and facility must have adequate drainage and be free of standing water. In areas where RMW is managed, pavements, floors, and drains must be properly maintained to prevent ponding, and facilitate discharges to sanitary sewers.

(d) Process changes. The department must be notified, in accordance with the provisions of subdivision 360-17.4(e) of this section, of all process changes before they are implemented. If a permit modification is required for a process change, the procedures for such modification are contained in subdivisions 360-1.8(e) and 360-1.9(c) of this Part.

(e) Reporting. In addition to the requirements of subdivisions 360-1.4(c) and 360-1.14(i) of this Part, all correspondence with the department must be submitted, in writing, to the regional solid waste engineer in the departmental region in which the facility is located, with a copy sent to the director, Division of Solid Waste, New York State Department of Environmental Conservation, 50 Wolf Road, Albany, NY 12233-4010. The permittee or his representative must:

(1) immediately notify, by telephone, the regional solid waste engineer in the departmental region in which the facility is located, if an unscheduled facility shutdown exceeds 24 hours. Within 72 hours a written report of the incident must be sent to the individuals identified in subdivision 360-17.4(e) of this section;

(2) prepare and file a quarterly report, compiled on a weekly basis on a form provided by, or acceptable to, the department. Copies of the report must be received by individuals identified in subdivision 360-17.4(e) of this section within 30 days after the end of each quarter. Reports must include copies of operating information, such as verification of operating parameters recorded in accordance with paragraph 360-17.5(a)(6), and subdivisions 360-17.5(c) and 360-17.5(d) of this Subpart, receipt and disposition of untreatable and unauthorized waste, and other pertinent data;

(3) in addition to the quarterly reports, prepare and file with the department, an annual report on a form provided by, or acceptable to, the department by February 28 for the previous calendar year. The annual report must be sent to the individuals identified in subdivision 360-17.4(e) of this section; and

(4) maintain for each RMW treatment unit and each destruction unit, a handwritten or computer-based log, recording as appropriate for each load: the date, time, name of operator, type (i.e. sharps, standard load, no-sharps, etc.) and amount of RMW treated and RMW destroyed, the operating parameters, the post-treatment readings on all time/temperature-sensitive indicators, the condition of any temperature-sensitive tape, the use and results of challenge testing, the use of any other department-approved operating parameter indicators, any post-destruction readings or measurements, and any unusual occurrences during the operation of the unit. Copies of such logs, readings, conditions and occurrences shall be submitted with each quarterly report during the first year of operation. Thereafter, this information must be maintained at the facility in accordance with subdivision 360-1.14(i) of this Part.

(f) Odor and volatile organic control. The facility must control the emission of odors, volatile organic compounds, or other contaminants to the outside air which could threaten public health or the environment, or could unreasonably interfere with the comfortable enjoyment of life and property. Ventilation systems must be designed and operated to prevent the release of these contaminants, except through exhaust vents or stacks fitted with odor or other air pollution controls if required by the commissioner. This may include the maintenance of negative air pressure, as established by the applicant to be adequate for this purpose, inside the building areas in which treatment takes place. The means of instituting such control measures shall be described in the engineering report required under subparagraph 360-17.3(a)(4)(vi) of this Subpart.

(g) Certification. The facility operator must certify, on a form to be provided by the department, that each load of treated RMW, or each load of treated and destroyed medical waste, that is transported from the facility has been treated, or treated and destroyed, in accordance with the approved operation plan, the requirements of section 360-17.5 of this Part, and the facility permit to construct and operate. The certification form must be signed and dated by the shift supervisor or facility manager and, where appropriate, must be accompanied by a medical waste tracking form in accordance with section 364.9 of this Title. The original certification form must accompany the treated RMW, or the treated and destroyed medical waste, to the authorized solid waste incinerator or landfill facility. Copies of the certification form must be maintained at all solid waste management facilities which process, store or handle the treated RMW, or the treated and destroyed medical waste. The original and all copies of the certification form must be maintained at these solid waste management facilities in accordance with the provisions of subdivision 360-1.14(i) of this Part. Transfer stations are not required to maintain copies of certification forms.

§360-17.5 Requirements for treatment of regulated medical waste.

(a) Operating parameters for autoclaves. An autoclave used to treat RMW shall be operated in accordance with the following minimum requirements:

(1) when operating a gravity flow autoclave, RMW shall be subjected to:

(i) a temperature of not less than 250 F and a pressure of 15 pounds per square inch gauge (psig) for an autoclave residence time of not less than 60 minutes;

(ii) a temperature of not less than 275 F and a pressure of 31 psig for an autoclave residence time of not less than 45 minutes; or

(iii) a temperature of not less than 300 F and a pressure of 52 psig for an autoclave residence time of not less than 30 minutes;

(2) when operating a vacuum autoclave, RMW shall be subjected to a minimum of one pre-vacuum pulse to purge the autoclave of all air, and the following:

(i) a temperature of not less than 250 F and a pressure of 15 psig for an autoclave residence time of not less than 45 minutes; or

(ii) a temperature of not less than 275 F and a pressure of 31 psig for an autoclave residence time of not less than 30 minutes;

(3) the minimum operating parameters for temperature, pressure, and residence time proposed for each autoclave unit shall be determined during start-up of the facility utilizing the approved validation testing program and standardized loads;

(4) notwithstanding paragraphs (1) and (2) of this subdivision, a different combination of operating parameters for time, temperature, and pressure may be used to autoclave RMW only if such combination is first proposed by the applicant, and approved in writing by the commissioner. The commissioner, in consultation with the commissioner of the New York State Department of Health, will not grant approval unless such combination is proven on the basis of validation testing, including testing of its ability to completely and consistently kill the approved biological indicator at the maximum design capacity of each autoclave unit. Biological indicators for autoclaves shall be Bacillus stearothermophilus spores using vials or spore strips, with at least 1 x 104 spores per milliliter. Under no circumstances will an autoclave have minimum operating parameters less than a residence time of 30 minutes, regardless of temperature and pressure, a temperature less than 250 F, or a pressure less than 15 psig;

(5) RMW shall be autoclaved in the container which is received at the facility, unless reusable containers are utilized. Autoclave procedures shall be those described in the operation plan. Containers shall be placed in the autoclave in the same manner that was used during validation testing; and

(6) each autoclave shall have graphic or computer recording devices which will automatically and continuously monitor and record dates, time of day, load identification number, and operating parameters throughout the entire length of the autoclave cycle. Temperatures shall be determined by the use of thermocouples and probes placed at approved locations within each autoclave unit. Autoclave temperature-sensing devices and time/temperature-sensitive indicators shall be placed in the specific locations of each load, as identified in the approved operation plan. Also, before autoclaving, the operator of the autoclave shall affix temperature-sensitive tape to the containers, as identified in the approved operation plan. Such locations shall take into consideration the coldest points in each autoclave, and those areas where steam is least likely to penetrate. These time/temperature-sensitive indicators and temperature-sensitive tape must be capable of indicating that the minimum approved temperature and residence time, or temperature, has been reached. RMW shall not be considered properly treated unless all time/temperature-sensitive indicators or temperature-sensitive tapes indicate that the required time or temperature was reached during the autoclave process. If for any reason a time/temperature-sensitive indicator or a temperature-sensitive tape, does not indicate that the required temperature or residence time was reached, the entire load of RMW must be autoclaved again until the proper temperature, pressure, and residence time is achieved. If any load of RMW must be autoclaved again, a report on the incident must be received within 72 hours by the individuals identified in subdivision 360-17.4(e) of this Subpart.

(b) Validation testing program. In addition to the requirements of subdivision 360-17.5(a) or subdivision 360-17.5(d) of this section, each RMW treatment unit shall successfully complete the approved validation testing program prior to commercial operation in accordance with the following requirements:

(1) no RMW will be considered treated by a RMW treatment unit until the results of validation testing conducted on each RMW treatment unit have been reviewed and approved, in writing, by the New York State Department of Health, in accordance with the approved validation testing program. Therefore, RMW treated during validation testing must be either transported to, and treated at, an approved facility prior to disposal, or stored on-site until the results of the validation testing program have been approved, in writing, by the New York State Department of Health.

(2) validation testing and analysis procedures shall be contained in the validation testing program and shall be submitted to the department with the application for a permit to construct and operate in accordance with subdivision 360-17.1(e) of this Part. Facility start-up can not commence until the validation testing program has been approved. The results of such validation testing must be approved, in writing, by the New York State Department of Health before commercial operation will be permitted. Based on the results of the validation testing program, minimum operating parameters will be established for each RMW treatment unit.

(3) testing, and if necessary, retesting, shall be conducted on each RMW treatment unit to determine the required minimum operating parameters for proper treatment of RMW. Standardized loads will be developed for the maximum design capacity of each RMW treatment unit and used in the validation testing of each unit. Standardized loads, as described in the operating plan, must simulate anticipated worst case operating conditions and make use of actual RMW that is expected to be treated by the facility, including materials believed to be difficult to treat. No RMW shall be treated which has characteristics, such as a greater density or lower rate of steam penetration, different from that of the standardized load. During each validation test, each load of RMW shall contain at least one biological indicator sample per 100 pounds of RMW being processed, with a minimum of five samples per standardized load. There must be positive quality control when conducting validation testing (i.e., a biological indicator sample not exposed to treatment). Temperature probes will also be placed at locations within the standardized load in accordance with the approved validation testing program.

(c) Challenge testing. Challenge testing shall include the following:

(1) Challenge testing shall be conducted to verify the effectiveness of each RMW treatment unit and the RMW treatment process, including tests of the ability of each RMW treatment unit to completely and consistently kill the approved biological indicator. Challenge testing, using the standardized load as approved in the operation plan, shall be conducted for each RMW treatment unit at least once every 40 hours of operation, and shall include a detailed visual inspection as described in the maintenance and monitoring plan. A separate and detailed log shall be maintained for each RMW treatment unit, recording the dates and results of each challenge test and visual inspection.

(2) During each challenge test, each load of RMW shall contain one biological indicator sample for every 200 pounds of RMW being processed, with a minimum of five biological indicator samples for each standardized load. The operation plan must completely describe the methods of challenge testing, sampling, handling, and the biological indicator sample culturing procedures. Each biological indicator sample shall be placed in the center of an approved, nonputrescible material that will simulate characteristics (i.e., type, density, composition, moisture content, and rate of steam penetration) of the RMW expected to be treated at the facility. Each biological indicator sample must be placed so it will be easily and safely removed from the load of RMW after treatment. Biological indicator sample packaging materials, methods, and the standardized load must be approved, in writing, by the New York State Department of Health, and contained in the operation plan. There must be positive quality control when using these biological indicator samples (i.e., biological indicator samples not exposed to treatment).

(3) The results of the challenge tests will be used to evaluate the working conditions of each RMW treatment unit. The cause of any positive biological indicator growth during challenge testing shall be used to determine what adjustments are necessary to the RMW treatment unit, its appurtenances, and the treatment process. Upon receipt of information indicating positive biological indicator growth, immediately notify by telephone, the regional solid waste engineer in the departmental region in which the facility is located. A written incident report on the positive biological indicator growth and the actions undertaken at the facility to correct the cause of such biological indicator growth must be received within 72 hours by the individuals identified in subdivision 360-17.4(e) of this Subpart.

(d) Operating parameters for other RMW treatment technologies. Operating requirements for other RMW treatment technologies will be established by the department on a case-by-case basis, in consultation with the New York State Department of Health, at the time of permit issuance.