N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.4

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

Section 365-2.4 - Permit application requirements

A facility that treats, stores or transfers RMW, which is not exempt or subject to the registration provisions of Subpart 365-1 or section 365-2.3 of this Part, must obtain a permit from the department. The permit application must include the requirements identified in this section and section 360.16 of this Title, and include a description of how the facility will comply with the operating requirements of section 360.19 of this Title, and sections 365-2.5, 365-2.6, 365-2.7, and 365-2.8 of this Subpart. An application for a permit under this section must include:

(a) A waste control plan that describes:

(1) the notification program to instruct the generators who will use the facility of the types of RMW that will be accepted and/or treated at the facility including source and quantity. The description of the quantity must specify the expected average and maximum daily and annual amounts, on a weight and volume basis. These quantities must be specified for each general category of RMW;

(2) the service area, that includes a list of all planning units and other generators that are served must be included;

(3) special waste management if any of the following wastes are accepted:

(i) reusable secondary containers including sharps containers;

(ii) reusable medical devices, disposed as RMW by the generator;

(iii) waste (including sharps) containing pharmaceuticals or other chemicals;

(iv) wastes from a biosafety level 3 or 4 laboratory or other generation area; or

(v) waste containing select agents or toxins of biological origin listed in 7 CFR Part 331, 9 CFR Part 121 and 42 CFR Part 73, as incorporated by reference in section 360.3 of this Title, or other infectious wastes.

(4) how the facility will ensure that it only receives RMW or other wastes capable of being managed at the facility;

(5) how the facility will identify, store, and dispose of all waste received that cannot be managed at the facility, such as anatomical or pathological waste;

(6) the methods used to inspect all containers received to ensure that they are in compliance with this Subpart;

(7) the methods used to manage the waste that ensures odor, litter and vectors are controlled;

(8) how the facility will be managed to ensure compliance with all applicable storage requirements;

(9) how the facility will handle spills, breached containers or contaminated equipment used for handling the waste;

(10) how inventory will be managed; and

(11) the method that will be used to manage the required tracking forms.

(b)Operation and maintenance plan.

The operation and maintenance plan must include:

(1) a description of the overall operation of the facility including:

(i) a radioactive waste detection plan that includes procedures for detecting prohibited radioactive material; operation and maintenance documents for radiation detectors including investigation alarm set point settings and calibration methods; and response procedures to be implemented when radioactive waste is detected;

(ii) the method for unloading; and

(iii) the method for decontaminating emptied reusable RMW containers and facility equipment which are contaminated with RMW as follows:

(a) for cleaning, use of a detergent and sufficient agitation or pressure to remove visible contamination from a surface; and

(b) for disinfection, exposure to hot water at a temperature of at least 180 degrees Fahrenheit (82 degrees Celsius) for a minimum of 15 seconds, or exposure to a chemical disinfectant or a pesticide registered for use by the department and used according to the registered label directions.

(2) a list of the type, purpose, size, capacity, and associated detention times for all RMW storage, treatment, and transfer equipment and structures, with supporting capacity calculations;

(3) a process flow diagram for RMW management during operation. The flow diagram must indicate the average and maximum daily quantity of material handled on a weight and volume basis;

(4) a description of all security measures used during operation of the facility;

(5) the operational procedures for each major facility component involved in RMW management;

(6) a description of monitoring and inspection that will be used to identify and correct equipment malfunctions or deteriorations, operator errors, and other malfunctions;

(7) a description of the proposed measures to handle RMW during periods of routine maintenance, emergencies, equipment breakdown, or facility start-up and shutdown;

(8) a description of the daily cleaning and maintenance operations and scheduled downtime maintenance each year and anticipated schedules for major equipment replacement;

(9) a description of how all equipment, personal protective equipment (PPE), or other items that have contacted RMW will be disinfected including identification of the disinfectant or pesticide proposed to be used; and

(10) a list of receiving facilities that will be used for treatment or disposal.

(c)Personnel training and safety plan.

The plan must include:

(1) a description of the employee training program that will be used to teach employees how to correctly operate the equipment they must operate and to discover problems with that equipment;

(2) a general awareness and familiarization component that outlines how each employee will become familiar with the risks associated with the handling of the RMW and how those risks can be minimized; and

(3) a training component on how to manage compromised packaging, spills, emergencies, or unauthorized wastes.

(d)Contingency plan.

The plan must describe the actions that will be taken to address potential operational problems including, but not limited to, compromised packaging, equipment malfunction or breakdown, delivery of unauthorized waste, waste not packaged appropriately, spills, fire, explosion, power failure, excessive noise, unacceptable odors, litter, and vectors. The plan must also include a contingency for treatment or disposal should processing equipment be non-functional for a period longer than seven calendar days.

(e)A wash-water management plan.

The plan must describe the facility's drainage system and the amount, with supporting calculations, of wash-water emanating from the cleaning of areas, reusable containers or equipment that have come in contact with RMW and the method to collect, store, treat or dispose of wash-water.

(f) Treatment equipment description.

Treatment facilities must provide a detailed description of the treatment device(s) including:

(1) an outline of the equipment features (e.g., manufacturer name, model number, capacity and material of construction), ancillary equipment, physical characteristics and function; and a drawing of the equipment showing piping and instrumentation;

(2) evidence of manufacturer efficacy testing, including the use of biological indicators analyzed by an independent laboratory;

(3) a list of the operating parameters (e.g., temperature, pressure, time, irradiation or chemical levels, etc.) that will be attained for microbial inactivation and treatment;

(4) the frequency, location, and method for monitoring the operating parameters;

(5) the procedures for and frequency of calibration of all instruments and controls;

(6) the procedures for loading the treatment device and unloading the treated waste; and

(7) for facilities using an alternative treatment system, a copy of the NYSDOH approval issued to the system"s manufacturer or operator.

(g)Validation plan for treatment systems.

The plan must describe the procedures for validation and bio-challenge testing including, but not limited, to the types of biological indicators employed, the timing of all testing, the location of all monitoring points, protocols and methods for monitoring, laboratory analytical techniques employed, and the laboratory(ies) that will be used for analyses. The plan must also provide sufficient information to address each of the applicable requirements identified in sections 365-2.5, 365-2.6 and 365-2.7 of this Subpart.

(h)A certification that the facility conforms with existing local zoning laws or ordinances.

(i) Closure plan. The plan must describe how all the equipment and facility surfaces will be disinfected, tested for microbial inactivation and decontamination, and how the facility will be properly closed.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-2.4

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