N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-1.2

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

Section 365-1.2 - Management of RMW by the generator

(a) Waste management plan.

(1) A generator of RMW is responsible for properly identifying and segregating the waste and must develop, document and implement policies and procedures specific to the management of RMW generated on-site, and for labeling RMW based on the planned method of treatment (e.g., autoclave, incineration, etc.) off-site. The policies and procedures must include, but are not limited to:

(i) a description of the types, and method(s) for treatment or disposal of RMW generated on-site;

(ii) the procedures, including the employee training, for safe handling and transport of the RMW within the facility from the point of generation or acceptance to the point of storage and/or treatment;

(iii) a description of short and long term storage areas including, as applicable, patient care areas, laboratories, production and testing rooms, etc. which details the location, ventilation and capacity of each storage area, and the length of time waste is to be retained in each area;

(iv) the titles and contact information for persons responsible for monitoring compliance with the waste management plan;

(v) for facilities that treat RMW on-site, an operation plan for each treatment system employed; and

(vi) a contingency plan that addresses emergencies, spills, and other unexpected events.

(b) Containment and storage.

(1) RMW must be separated from other waste as soon as practicable at the point of generation prior to storage, treatment or disposal.

(2) Containers holding RMW that cannot be treated by an autoclave or other approved treatment technology must be labeled accordingly. The label must identify waste types and acceptable treatment method (e.g., incinerate only, etc.).

(3) RMW that contains radioactive isotopes must be stored until decayed to a background radiation level prior to transport off-site, unless returned to the dispensing radiopharmacy or managed as a prohibited radioactive material.

(4) RMW must be contained in a primary container, defined in paragraph 365-1.2(b)(13) of this section.

(5) A sharps container must not be filled beyond the fill line indicated on the container.

(6) Fluids contained in leak-proof containers must be placed in a primary container, oriented in an upright position and secured to prevent leakage, and then placed in a secondary container, defined in paragraph 365-1.2(b)(12) of this section, prior to off-site transport.

(7) Sharps containers must be removed from patient care or use areas to a room or area designated for RMW storage when: the container has reached the fill line indicated on the container, is otherwise filled, or generates odors or other evidence of putrefaction, whichever occurs first.

(8) Other RMW containers, at a laboratory or other generation area must be moved to an RMW storage area when the container has reached the fill line indicated on the container, is otherwise filled, or generates odors or other evidence of putrefaction, whichever occurs first.

(9) An RMW storage area must be adequately sized for the volume of RMW generated between scheduled waste pick-ups by a transporter, or, for facilities treating the waste on-site, the volume of waste that can be treated on-site within a 24-hour period.

(10) An RMW storage area must:

(i) display prominent signage indicating the areas is used to store RMW;

(ii) be designed or equipped to prevent unauthorized access;

(iii) be designed or located to protect waste from the elements, and prevent access by vermin;

(iv) hold the waste at a temperature that prevents rapid decomposition and resultant odor generation;

(v) be appropriately ventilated; and

(vi) be of sufficient size to allow clear separation of RMW from any other waste, if waste other than RMW is stored in the same area.

(11) RMW must not be stored in a storage area for a period exceeding 30 days, except for a generator of less than 50 pounds of RMW per month that does not accept RMW for treatment from other facilities may store RMW until the container has reached the fill line on the container, is otherwise filled, or generates odors or other evidence of putrefaction, whichever occurs first. For bulk packaging, storage must be in accordance with subparagraphs (14)(vi) and (vii) of this subdivision. For radiological RMW, the RMW may be stored for a period of time necessary to allow decay to a background radiation level, or if long lived must be managed as a prohibited radioactive material (including waste disposal).

(12) Prior to transport of RMW off-site for treatment, the:

(i) primary containers, except sharps containers, must be placed in a secondary container and marked prominently with the universal biohazard symbol or the word Biohazard, and, if applicable, must be affixed with a label indicating that the contents require special handling (e.g., incinerate only, etc.); and

(ii) primary containers must be labeled with the name and address of the generating facility when placed in a secondary container that is a bulk container used by multiple generators.

(13) Requirements for primary containers.

(i) Primary containers, with the exception of sharps containers, must be a plastic bag that complies with the standards prescribed by 49 CFR 173.196, 173.197 and 173.199, as incorporated by reference in section 360.3 of this Title, and is certified by the bag manufacturer to meet federal requirements.

(ii) The primary container for discarded sharps must be rigid, leak-proof on the sides and bottom, puncture-resistant and closable, and may serve as a secondary container for purposes of transport, provided it meets the definition of a secondary container.

(iii) Primary containers must not be filled in a manner that results in the breakage of the container.

(iv) Primary containers in laboratory and clinical settings must be kept in secure locations (e.g., access restricted rooms) when in use and must be properly closed when moved to other locations. In other settings, primary containers must be properly closed at all times when not being filled.

(v) Only primary containers that have been approved for reuse by the United States Food and Drug Administration (FDA) may be reused.

(vi) Prior to transport off-site, RMW must be placed in commercially manufactured disposable (e.g., fiberboard boxes that meet USDOT HMR specifications) or reusable secondary containers.

(14) Requirements for secondary containers.

(i) Secondary containers must comply with the standards prescribed by the USDOT found at 49 CFR 173.134, 173.196, 173.197, and 173.199 as incorporated by reference in section 360.3 of this Title. Reusable secondary containers can include wheeled carts or roll-off bulk containers.

(ii) Reusable secondary containers must be inspected prior to return to use to verify that the containers are not defective (i.e., have no cracks or other defects, that the lid closes and, if available, the locking mechanism works) and are cleaned and disinfected. Reusable containers must be immediately cleaned and disinfected upon emptying if the liner is compromised, visual inspection yields evidence that the container's surface has come in contact with RMW prior to treatment, the contained waste includes cultures and/or stocks, or the contained waste has a highly infectious bioload.

(iii) Wheeled carts or bulk packaging used as secondary containers to contain RMW must be used exclusively to transport RMW.

(iv) Bulk packaging may not be used for the disposal of liquid blood or blood products, sharps, pathological waste, or contaminated animal carcasses or body parts, unless the waste is properly contained in rigid primary containers with enough absorbent material to absorb all liquid present and separated from other regulated medical waste by a leak-proof rigid barrier, divider or separate compartment.

(v) All wheeled carts and bulk outer packages used as secondary containers must be kept in a sanitary condition, disinfected before reuse, and must not be allowed to become putrescent.

(vi) Bulk packages that are roll-off containers (except those used for pathological waste, blood or blood products, or animal waste) that will be sent off-site may only be stored at the site of generation until the container is filled, or for 21 days if ambient temperatures are below 45 degrees Fahrenheit (7 degrees Centigrade) or for 14 days if above 45 degrees, whichever comes first, except that bulk packages that are putrescent must be immediately sent to the receiving facility.

(vii) Bulk packages that are roll-off containers used for pathological waste, blood or blood products, or animal waste that will be sent off-site may only be stored at the site of generation until the container is filled, or for seven days, whichever comes first. Bulk packages that are putrescent must be immediately sent to the receiving facility.

(viii) Bulk outer packaging may not be used for the transport of cultures and stocks containing select agents or toxins of biological origin listed in 9 CFR Part 121 and 42 CFR Part 73 as incorporated by reference in section 360.3 of this Title.

(ix) All internal surfaces of a reusable secondary container, except for reusable sharps containers, must be completely protected by a disposable liner, which may also function as the primary container provided it meets the criteria for a primary container, or the secondary container serves as both a primary and secondary container. The liner must be removed as a secured unit with the contained RMW and treated as RMW.

(15) Disposable single-use secondary containers, broken reusable containers or containers no longer in service must be treated as RMW unless decontaminated for recycling.

(16) RMW cannot be transferred from one container to another in a manner that compromises health and safety of the persons handling the RMW. RMW being moved from one container to another, or one location to another within a facility must, at a minimum, be secured in a primary container.

(17) Sharps or other secondary containers must not be opened for consolidation or other purposes unless the container is routinely reopened to add waste or the procedure has been approved as required by Subpart 365-2 of this Part.

(18) Movement of RMW within a facility from the point of generation to the point of storage or treatment must be by covered cart or other appropriately covered conveyance system marked prominently with labeling indicating that the contents are infectious or are RMW; provided, however, waste held in containers meeting the definition of secondary container may be transported within a facility from point of generation to the point of storage or treatment using an open conveyance system (e.g., laboratory cart, dolly, etc.) provided each container is labeled and appropriately closed. RMW must not be moved within a facility by gravity alone without control of impact (e.g., trash chutes, slides, etc.).

(19) RMW must not be compacted or compressed unless it has undergone treatment in accordance with Subpart 365-2 of this Part.

(c) Transfer of RMW for off-site treatment

(1) Generators of RMW must transfer the waste for off-site treatment only to a transporter authorized to transport RMW under Part 364 of this Title.

(2) Radiological RMW must be returned to the dispensing radiopharmacy, stored at the generator's location until the RMW has decayed to a background radiation level, or if long lived must be managed as a prohibited radioactive material (including waste disposal).

(3) A hard copy of a medical waste tracking form must accompany each load of RMW leaving the generator. The instructions on the tracking form must be followed.

(4) All municipal solid waste transported in a load containing RMW must also be treated as RMW, unless the RMW is separately contained in a secondary container or is otherwise kept separate from the MSW by leak-proof barriers.

(5) Any pharmaceutical waste that is unable to be separated at the site of generation must include a label that reads "Incinerate Only" on the secondary container and must be disposed at a RMW or municipal waste combustor that is permitted to accept non-hazardous pharmaceutical waste, or at another approved facility. Most non-hazardous pharmaceutical waste may not be disposed in sanitary sewers, septic systems or wastewater treatment systems. The following are the only types of pharmaceutical waste that may be disposed in sanitary sewers, septic systems or wastewater treatment systems: saline solution; lactate; nutrients such as glucose, vitamins, potassium or other salts; and electrolytes.

(6) Secondary containers, except for non-hazardous pharmaceuticals, must be labeled in accordance with the definitions and applicable classification criteria (e.g., RMW, Infectious Substances or Used Healthcare Products) required by 49 CFR 173.134, as incorporated by reference in section 360.3 of this Title. Each label must be printed on or affixed to a surface (other than the bottom) of the container and be located on the same surface of the container near the proper shipping name marking. Each label, whether printed on or affixed to a container, must be durable and weather resistant.

(7) If an infectious substance, secondary containers, except sharps containers, must be affixed with an "INFECTIOUS SUBSTANCE" label or marked with the fluorescent orange Universal "BIOHAZARD" symbol meeting the specification under 29 CFR 1910.1030(g)(1)(i) in accordance with 49 CFR 173.134, as incorporated by reference in section 360.3 of this Title, date of transport, and if applicable, that the contents (if containing pharmaceutical, chemical or pathological waste) require incineration. An "INFECTIOUS SUBSTANCE" label is not required on a non-bulk secondary container with a "BIOHAZARD" marking.

(d) Processing of RMW on-site.

(1) Unless otherwise exempt or required to obtain a permit under Subpart 365-2 of this Part, facilities (i.e. generators) described in this paragraph are subject to the registration provision of section 360.15 of this title. Each facility identified in this paragraph must obtain a registration from the Department but is not required to comply with section 360.19 of this Title:

(i) a facility that decontaminates or treats less than 500 pounds of RMW (including waste from a laboratory or other generation area operating at biosafety level 2 (BSL-2) per month of its own waste with autoclaves, a NYSDOH approved alternative treatment system; or with any Department-approved method of treatment of infectious waste regardless of how the waste is disposed; and,

(ii) a facility that decontaminates, inactivates or treats its own waste generated from a biosafety level 3 (BSL-3) or an animal biosafety level 3 (ABSL-3) laboratory or other generation area, subject to the following:

(a) Decontamination and treatment is performed with autoclaves, a NYSDOH-approved alternative treatment system, or with any Department-approved method of inactivation of infectious waste,

(b) The facility has a current registration number with the Federal Select Agent Program (FSAP) authorizing the facility to possess and work with select agents or toxins of biological origin listed in 7 CFR Part 331, 9 CFR Part 121 or 42 CFR Part 73 as incorporated by reference in section 360.3 of this Title, and

(c) BSL-3 and ABSL-3 wastes generated at these facilities must be decontaminated, inactivated or treated on-site and must be disposed of as RMW at a permitted RMW treatment facility.

(2) The facility registered pursuant to subparagraph 365-1.2(d)(1)(ii) may include another BSL-3 or ABSL-3 laboratory or other generation area at the same institution as the FSAP-registered area which utilizes the biosafety protocols approved as part of the FSAP registration and is overseen by the same institutional biosafety committee and environmental health and safety office, provided decontamination, inactivation or treatment of RMW complies with the Department's registration.

(3) Facilities subject to registration under paragraph 365-1.2(d)(1) of this subdivision must comply with the following operational requirements:

(i) A registered facility under this subdivision must have a written operation and maintenance plan that demonstrates that the RMW will be managed in accordance with this Subpart and sections 365-2.6 and 365-2.7 of this Part.

(ii) The operation and maintenance plan must identify the decontamination, inactivation or treatment locations, types and number of laboratories and types of devices (including devices used to treat waste water and pathological waste) that will be used to decontaminate or treat RMW. Decontamination, inactivation or treatment must comply with sections 365-2.6 and 365-2.7 of this Part.

(iii) The facility must have procedures to segregate RMW to be treated and treated RMW from other waste.

(iv) Each facility employee who will operate decontamination, inactivation or treatment equipment must be trained in the proper use of the equipment.

(v) The facility must maintain records for the operation of each decontamination, inactivation or treatment unit. A log must be maintained that includes the date, time, name of the employee operating each unit, the type and amount of RMW treated, and the dates and results of calibration, validation and bio-challenge testing.

(vi) The facility must maintain a contingency plan for emergencies and spill or release response and cleanup, which includes provisions for RMW storage during emergency situations. All spills and emergency situations must be immediately reported to the department.

(vii) Decontaminated, inactivated and treated waste must be sent for additional treatment to a facility authorized to treat RMW or disposed at a facility authorized to accept treated RMW for disposal. Each load of waste must be accompanied by a NYSDOH certificate of treatment.

(4) The following types of facilities are subject to regulation under Subpart 365-2 of this Part:

(i) a facility which decontaminates, inactivates or treats more than 500 pounds of RMW per month; and

(ii) a facility operating a BSL-3 or an ABSL-3 laboratory or other generation area that is not registered with the FSAP to possess and work with select agents or toxins of biological origin, or whose FSAP registration is no longer in effect and

(iii) a facility operating a BSL-4 or ABSL-4 laboratory or other generation area.

(e) Recordkeeping and reporting

(1) Recordkeeping. The following records must be maintained on-site for a minimum of three years and must be available for inspection and copying by the department.

(i) A record of RMW managed by quantity and category. Categories include cultures and stocks, human pathological waste, human blood and blood products, sharps, animal waste, and other (specify characteristics).

(ii) A record of how all RMW was managed, including treatment, if applicable. For treatment, copies of certificates of treatment must be retained. For shipment off-site for treatment, copies of tracking documents must be retained.

(iii) In addition, decontamination, inactivation and treatment facilities must comply with the recordkeeping requirements of Subpart 365-2 of this Part.

(2) Reporting. A report of the RMW generated annually, by quantity and category, must be submitted to the department upon request.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 365-1.2

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