N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.5

Current through Register Vol. 46, No. 45, November 2, 2024

Section 365-2.5 - Design and operating requirements

A facility required to obtain a permit under this Subpart must, in addition to the requirements identified in section 360.19 of this Title, design, construct, maintain, and operate the facility in compliance with the following criteria.

(a) An RMW tracking document must be received for each shipment of RMW accepted at the facility. The facility must not accept waste from unauthorized off-site sources (e.g., self-transporters, generators not authorized by the permit, etc.), or waste which is not accompanied by a tracking document. The tracking form must be completed as required as specified in the instructions on the form.

(b) A fixed radiation detection unit must be installed and operated at a location appropriate for the monitoring of all incoming RMW. In addition:

(1) the investigation alarm set point of the radiation detector must be set at least two times but no greater than five times background radiation levels;

(2) the concentration of radiation in any waste received may not exceed background radiation levels;

(3) background radiation readings at the facility must be measured and recorded at least daily;

(4) field checks of the radiation detector utilizing a known radiation source must be performed and recorded at least weekly;

(i) the radiation detector must be calibrated at least annually or more often as recommended by the manufacturer, and documentation describing the calibration must be maintained at the facility; and

(ii) each instance in which the radiation detector is triggered by a waste load must be documented and reported to the department by the next business day following the event. Recorded information must include the date the waste was received, transporter name, origin of the waste, truck number or other identifying marking, detector reading, disposition of the waste, and date of disposition.

(c) For storage and transfer facilities, the RMW must be maintained in the packaging as received, unless otherwise approved by the department. If any packages are broken, leaking or are otherwise compromised, the RMW must be handled as outlined in the contingency plan. The RMW may only be surrendered to a transporter permitted to transport RMW under Part 364 of this Title.

(d) Incoming RMW must be handled in accordance with the following criteria.

(1) RMW must not be accepted unless there is sufficient storage, transfer or treatment capacity.

(2) RMW must be inspected prior to unloading to ensure the RMW has been packaged appropriately. If any packages are broken, leaking or otherwise compromised, the RMW must be handled as outlined in the contingency plan. Containers of RMW must not be opened for inspection unless authorized by the department.

(3) RMW shipment in bulk packaging cannot be accepted, unless approved by the department as part of the waste control plan.

(4) The facility must record the date of arrival of each waste load at the facility, the original generator identification, package type and weight or volume, and the intended disposition of the waste. These documents may be maintained electronically.

(e) RMW handling and storage.

(1) Entry to the facility must be secured and controlled at all times through the use of gates or other means.

(2) A sign must be conspicuously posted at each entrance to the facility that identifies the types of waste that are acceptable for delivery to the facility and the types of wastes that are not accepted at the facility. This sign must be a minimum of 12 inches high by 18 inches wide and have lettering a minimum of one inch in height. Signs that read "CAUTION -REGULATED MEDICAL WASTE. VISITORS AND UNAUTHORIZED PERSONNEL MUST REPORT TO THE OFFICE." must be posted at each entrance to the facility. These signs must include the universal biohazard warning symbol.

(3) RMW must be completely contained and secured during storage and with appropriate blocking and bracing when moved by a vehicle during transport.

(4) RMW storage and handling procedures must minimize potential occupational exposures and release to the environment.

(5) Containers must be stored in an upright, stable and controlled manner that minimizes the potential for leakage. The top of the stacked containers must not be more than eight feet above the level of the floor. The containers must not be compromised by the manner of storage.

(6) Unauthorized wastes may be temporarily stored in areas specifically designed for these wastes on the facility site in accordance with the waste control plan.

(7) All buildings must be fully enclosed and must have an impermeable floor.

(8) RMW must not be processed to reduce the size prior to treatment, unless approved by the department as part of the operation and maintenance plan.

(9) RMW must not be compacted or compressed. RMW placed into bins for consolidation or treatment must be controlled to minimize aerosolization.

(10) Trash chutes or slides cannot be used to move RMW between containers, vehicles, or treatment devices unless the movement is controlled to maintain the integrity of the containers.

(11) Vehicles must be unloaded in a manner that does not cause containers to break or otherwise release RMW.

(12) Storage of RMW that has the ability to become putrescent is limited to:

(i) three days if the RMW is stored at 45 degrees Fahrenheit (seven degrees Celsius) or greater;

(ii) seven days if the RMW is stored at less than 45 degrees Fahrenheit (seven degrees Celsius) but greater than 32 degrees Fahrenheit (0 degrees Celsius); and

(iii) 30 days if the RMW is stored at 32 degrees Fahrenheit (0 degrees Celsius) or lower.

(13) RMW which becomes putrescent must be treated, refrigerated, or removed from the facility as soon as practicable.

(14) Non-putrescent RMW can be stored above 45 degrees Fahrenheit (seven degrees Celsius) for a maximum of 15 days, and a maximum of 30 days if stored at or below 45 degrees Fahrenheit (seven degrees Celsius).

(15) Treated RMW must be removed from the facility within 30 days.

(16) The facility must be maintained in a clean and sanitary condition, and implement a written schedule of appropriate cleaning and disinfection.

(17) The unloading and loading areas must be adequately sized and designed to facilitate efficient transfer of RMW to and from the collection vehicles and the unobstructed movement of vehicles. All unloading and loading must be performed within a building and on a covered concrete or asphalt surface.

(f) RMW recovery and recycling. Recovery of RMW for third-party reprocessing of medical devices, or for reuse or recycling of materials must comply with the following.

(1) RMW and used medical devices generated from neurosurgery cannot be recovered or recycled.

(2) Used medical devices may be sent to a reprocessor for preparation for reuse without treatment.

(3) Used medical devices source separated at healthcare facilities that are managed at RMW processing facilities must be transported directly to the manufacturer, reprocessor or remanufacturer.

(4) Recovery, segregation and sorting of used medical devices from RMW received from healthcare facilities. Recovery, segregation and sorting must employ robotic or mechanical equipment, and control the release of microorganisms during processing.

(5) RMW to be recycled must be treated with an autoclave in accordance with the RMW treatment requirements of sections 365-2.6 and 365-2.7 of this Part prior to being sent for recycling.

(6) Bio-challenge testing must be conducted in accordance with this Subpart for each load of waste treated before recycling. Bio-challenge testing must demonstrate no growth in 'Bacillus' spores for each load of waste proposed to be recycled.

(7) Materials recovered for recycling from the RMW stream must be stored at the treatment facility until results of bio-challenge testing results have been obtained. If results indicate that treatment was not sufficient, the materials must be treated again and retested.

(g) The facility must maintain financial assurance in an amount sufficient to cover the cost of closure of the facility as specified by sections 360.21 and 360.22 of this Title.

(h) The facility must provide proof of liability insurance or other form of financial security deemed sufficient by the department to meet all responsibilities in case of release of RMW waste to the environment causing contamination.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.5

Adopted New York State Register September 20, 2017/Volume XXXIX, Issue 38, eff. 11/4/2017

Amended New York State Register June 7, 2023/Volume XLV, Issue 23, eff. 7/22/2023

Amended New York State Register June 21, 2023/Volume XLV, Issue 25, eff. 7/23/2023