6 CRR-NY 365-2.3NY-CRR
STATE COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 6. DEPARTMENT OF ENVIRONMENTAL CONSERVATION
CHAPTER IV. QUALITY SERVICES
SUBCHAPTER B. SOLID WASTES
PART 365. REGULATED MEDICAL WASTE AND OTHER INFECTIOUS WASTES
SUBPART 365-2. RMW TREATMENT, STORAGE, AND TRANSFER FACILITIES
6 CRR-NY 365-2.3
6 CRR-NY 365-2.3
365-2.3 Registered facilities.
Facilities of the following types must register with the department prior to treatment, storage or transfer of RMW, unless otherwise exempt. Facilities required to register with the department are subject to Part 360.15 of this Title but are not subject to section 360.19 of this Title.
(a) A storage facility for radiological RMW, including used sharps or other used medical devices, at a radiopharmacy, provided the sharps or other medical devices were dispensed by the radiopharmacy, and the following conditions are satisfied.
(1) In addition to the container requirements provided in Subpart 365-1 of this Part, radiological RMW destined for disposal must be stored at the radiopharmacy until radioisotopes have decayed to a background radiation level. Once decayed, the RMW can be stored for a maximum of 30 days.
(2) The radiopharmacy must have written policies and procedures for the safe handling and storage of the waste within the facility.
(3) Storage areas for radiological RMW must be adequately sized for the volume of RMW generated between scheduled waste pick-ups by a transporter.
(4) Storage areas for radiological RMW must:
(i) display prominent signage indicating the area 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 vectors;
(iv) hold the waste at a temperature that prevents rapid decomposition and resultant odor generation, if necessary;
(v) be appropriately ventilated;
(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; and
(vii) the top of the stacked containers must not be more than six feet above the level of the floor. The integrity of the containers must not be compromised by the manner of storage.
(5) Decayed radiological RMW that leaves the radiopharmacy must be accompanied by an RMW tracking document.
(b) A treatment facility, except for a biocontainment facility at a Biosafety Level 3 or 4 laboratory, located at the site of RMW generation, which treats less than 500 pounds of RMW per month from the on-site generator. The treatment facility cannot treat waste containing select agents or toxins of biological origin listed in 9 CFR part 121 or 42 CFR part 73 as incorporated by reference in section 360.3 of this Title. The on-site treatment facility must comply with the following conditions:
(1) The facility has a written operation plan that demonstrates that the RMW will be managed in accordance with this subdivision.
(2) The treatment of RMW must comply with sections 365-2.5, 365-2.6 and 365-2.7 of this Subpart.
(3) The facility must have procedures to segregate RMW to be treated from other waste.
(4) Each facility employee who will operate treatment equipment must be trained in the proper use of the treatment equipment.
(5) The facility must maintain records for the operation of the treatment unit. A log must be maintained that includes the date, time, name of the employee operating the unit, the type and amount of RMW treated, and the dates and results of calibration, validation and bio-challenge testing.
(6) The facility must maintain a contingency plan for emergencies and spill cleanup, which includes provisions for RMW storage during emergency situations.
(c) Healthcare facilities licensed pursuant to the PHL that treat, store or dispose of RMW from other generators (pursuant to written agreements with or among other generators filed with the NYSDOH and the department) for treatment, or are not operated by the healthcare facility. The operator of the facility must have and adhere to an operation plan for the handling and disposal of RMW approved by the department. The operation plan must include the following:
(1) A method of receiving wastes which ensures that RMW is handled separately from other wastes until treatment or disposal is accomplished and which prevents unauthorized persons from having access to or contact with the waste.
(2) A method of unloading and processing of RMW which limits the number of persons handling the waste and minimizes the possibility of exposure of employees and the public using or visiting the facility to RMW.
(3) A method of decontaminating emptied reusable RMW containers, transport vehicles or facility equipment which are known or believed to be contaminated with regulated medical waste.
(4) The provision and required use of gloves and other protective clothing to protect any facility employee who handles RMW.
(5) The means of decontamination of any person having had bodily contact with RMW while transporting the waste to the treatment or disposal site or while handling or disposing of the waste at the site.
(6) A quantification of the maximum amount of RMW to be treated, stored, or disposed of per month.
(7) A new or revised operation plan for treatment, storage or disposal of RMW shall be prepared whenever there is an increase of more than 25 percent in the maximum quantity of RMW receiving treatment, storage or disposal per month by the facility or when changes are otherwise made in an existing operation plan.
(8) The treatment of RMW must comply with sections 365-2.5, 365-2.6 and 365-2.7 of this Subpart.
(9) The facility must have procedures to segregate RMW to be treated from other waste.
(10) Each facility employee who will operate treatment equipment must be trained in the proper use of the treatment equipment.
(11) The facility must maintain records for the operation of the treatment unit. A log must be maintained that includes the date, time, name of the employee operating the unit, the type and amount of RMW treated, and the dates and results of calibration, validation and bio-challenge testing.
(12) The facility must maintain a contingency plan for emergencies and spill cleanup, which includes provisions for RMW storage during emergency situations.
(13) Approval for acceptance of RMW at a treatment, storage or disposal facility may be withdrawn by the department for noncompliance with the operation plan.
(14) As a condition of approval of a registration, any person who operates a facility for the treatment, storage and disposal of RMW shall 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 such waste causing damage.
6 CRR-NY 365-2.3
Current through March 15, 2022
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