Subpart 360-10:Regulated Medical Waste Storage, Transfer, and Disposal
(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)
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]
- 360-10.1 Applicability and exemptions.
- 360-10.2 Definitions.
- 360-10.3 Permit to construct and operate application requirements.
- 360-10.4 Operational requirements.
- 360-10.5 Disposal.
§360-10.1 Applicability and exemptions.
(a) Applicability. Except for the exemptions of section 360-1.7(b) of this Part and subdivision (b) of this section, all facilities involved with the storage, transfer and disposal of regulated medical waste (RMW) are subject to the requirements of this Subpart and Subpart 360-1 of this Part. Facilities treating RMW must comply with the applicable provisions of Subparts 360-1, 360-3 and 360-17 of this Part and Part 219 of this Title. RMW storage and transfer facilities are not authorized to accept low-level radioactive waste, solid waste, treated RMW or treated and destroyed medical waste (TDMW), unless such authorization is specifically granted, in writing, by the department.
(b) Exemptions. A facility or site involved with the storage or transfer of RMW is exempt from this Part for RMW storage or transfer activities if that facility or site:
(1) is located on the site of, and operated by, a health care facility licensed pursuant to article 28 of the Public Health Law or a clinical laboratory licensed pursuant to section 571 of the Public Health Law. RMW may be accepted by licensed health care facilities or clinical laboratories from other generators of RMW, provided the generator meets the requirements of section 364.9(e)
(2) of this Title. Written agreements between each generator and the licensed health care facility or clinical laboratory must be on file with the department and the New York State Department of Health (DOH). Storage and transfer facilities located on-site of licensed health care facilities and clinical laboratories, but not operated by the employees of such facilities, are not exempt from this Part;(2) is used for the non-profit collection of household medical waste sponsored by a community or government organization in accordance with section 360-1.7(b)(6) of this Part; or
(3) is used for on-vehicle storage by a permitted transporter storing RMW in accordance with section 364.9 of this Title, if such storage occurs on the original vehicle transporting the RMW from the point of initial RMW pickup to the point of final delivery. Such on-vehicle storage activities may include, but not be limited to overnight on-the-road stops, and stops for meals, fuel and driver comfort. The consolidation of any RMW between vehicles is a transfer activity subject to the requirements of this Subpart.
For the purposes of this Subpart, the definitions contained in Subparts 360-1 and 360-17 of this Part, and section 364.9 of this Title apply.
§360-10.3 Permit to construct and operate application requirements.
In addition to the applicable requirements of Subpart 360-1 of this Part, applications for a permit to construct and operate a RMW storage or transfer facility must contain the following:
(a) Regional plan or map. The regional plan or map must delineate the service area of the proposed transfer station.
(b) Engineering plan. The engineering plan must include:
(1) site conditions and projected site use including all site structures (such as buildings, fences, gates, entrances and exits, parking areas, on- site roadways and signs) and the location of all water supplies;
(2) property boundaries, access roads, the location of all surface water bodies and the location of 100-year floodplain boundaries;
(3) all proposed structures and areas designated for unloading, sorting, storage and loading, including dimensions, elevations and floor plans of these structures and areas and the general process flow; and
(4) adjacent properties including the location of public and private water supplies on these properties.
(c) Engineering report. The engineering report must include:
(1) a description of the general operation of the proposed facility including the general origin, composition and expected weight of all RMW to be accepted at the facility, the maximum time any such waste will be stored and where all waste will be treated, the proposed capacity, operating hours and expected life of the facility;
(2) a description of all machinery and equipment to be used, including radiation monitoring equipment, and any associated design capacities;
(3) a proposed transfer plan specifying the transfer route, the number and type of transfer vehicles to be used and how often RMW will be transferred to the treatment or disposal facility; and
(4) a description of the facility's drainage system and water supply system.
(d) 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 which causes bodily injury or property damage, including liability for environmental restoration resulting from negligence in operation.
(e) Design requirements for storage and transfer facilities. Unless specifically authorized by the department in writing, a RMW storage or transfer facility will only be permitted for the management of untreated RMW. If other solid wastes are being considered for handling at the facility, the application must demonstrate how mixing of untreated RMW with other solid waste will be prevented. All RMW storage and transfer facilities must be designed in accordance with the following provisions:
(1) Unloading and loading areas.
(i) The unloading and loading areas must be adequate in size and design to facilitate efficient transfer of RMW to and from the collection vehicles and the unobstructed movement of vehicles.
(ii) The unloading and loading areas must be constructed of concrete or asphalt paving material, be equipped with adequate drainage structures, and be free of standing water.
(iii) All processing, transfer, sorting and storage areas must be located within an enclosed building or fixed covered area.
(iv) Provisions must be made for weighing all RMW transferred at the facility.
(v) Radiation detection devices for radioactivity assessment must be installed in a location appropriate for the monitoring of all incoming waste.
(2) On-site roads.
(i) The facility must be designed to accommodate expected traffic flow in a safe and efficient manner.
(ii) The road surface design must be suitable for heavy vehicles and the road base must be capable of withstanding expected loads.
(iii) On-site roads must be passable by loaded collection and transfer vehicles in all weather conditions and provisions must be made for deicing ramps.
(f) Operation plan. The operation plan, in addition to addressing the operating requirements contained in section 360-10.4 of this Subpart, must include the following:
(1) 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;
(2) a method of unloading and processing RMW that limits the number of persons handling that waste and minimizes the possibility of RMW exposure to employees and the public using or visiting the facility;
(3) a method of monitoring the incoming waste to prevent the acceptance of radioactive waste and unauthorized waste at the facility;
(4) a method of decontaminating empty reusable RMW containers, transport vehicles and facility equipment;
(5) the required use of clean gloves and clean uniforms along with other protective clothing to provide protection for employees against exposure to RMW;
(6) the means of decontaminating any person who has bodily contact with RMW while handling the RMW at the site;
(7) the quantity on a weight basis, of the amount of RMW handled, stored or transferred each month; and
(8) the means of decontaminating the surfaces of transport vehicles that have come in contact with spilled or leaked RMW.
(g) Contingency plan. The contingency plan must provide procedures to be used for emergency and other situations such as spills of RMW, rupture of plastic bags and boxes and equipment failure. This plan must include procedures for:
(1) cleanup, protection of personnel, disposal of spill residue, repackaging of RMW and alternate arrangements for RMW treatment, storage and disposal. In the case of extended periods of storage, provide procedures, such as refrigeration, to prevent the RMW from becoming putrescible; and
(2) immediate notification by telephone of the regional solid waste engineer if the facility contingency plan was activated for such occurrences as fires, spills, contamination of any person or other emergencies. A written report must be submitted to the individuals identified in subdivision 360-10.4(p) of this Subpart.
(h) Personnel training plan. The personnel training plan must describe training that will be provided to all staff involved in the handling of RMW. Personnel training must include a thorough explanation of the operation plan, contingency plan, and the safe handling of RMW. Facility personnel must successfully complete the personnel training required in the personnel training plan within three months of the date of their employment. Prior to handling RMW, each employee must complete personnel safety training that includes the handling and management of RMW and worker protection.
§360-10.4 Operational requirements.
Facilities subject to this Subpart must comply with the following requirements:
(a) 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 are to be maintained and available for reference and inspection at the facility.
(b) The owner or operator of any facility used for the storage or transfer of RMW must, in addition to complying with the applicable requirements set forth in section 360-1.14 of this Part, adhere to a department-approved operation plan for the handling, storage and transfer of RMW.
(c) A new or revised operation plan for the storage or transfer of RMW must be prepared whenever the maximum quantity, on a weight basis, of RMW stored or transferred per month by the facility exceeds 25 percent of the average quantity of RMW stored or transferred in the previous three months, or when changes are otherwise made in an existing operation plan. The new or revised operation plan must be submitted within 30 days of exceeding the 25 percent level. The operation plan must be sent to the regional solid waste engineer in the office of the department administering the 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, 625 Broadway, Albany, NY 12233-4010.
(d) Approval for acceptance of RMW at a storage or transfer facility may be withdrawn by the department for noncompliance with the operation plan or Part 364 of this Title. The permittee may request a hearing after such withdrawal in accordance with subdivision 27-1517.3 of the ECL or section 621.14 of this Title.
(e) All RMW received at the facility must be packaged, labeled and transported in accordance with section 364.9 of this Title.
(f) If the facility is authorized to accept such waste, the delivery of treated RMW or TDMW must be accompanied by a certification form as described in section 360-17.4(g) of this Part.
(g) All areas within the facility site must be free of standing water. All drainage from washing and cleaning areas must be treated or disposed of in compliance with all applicable Federal and State regulations.
(h) The maximum duration for storage or containment of RMW must be limited to seven days, unless prior written approval is received from the department. RMW must not be allowed to become putrescent.
(i) Storage of RMW must be in a secure, vector-free, dry area and in a manner and location that minimizes the possibility of exposure to the environment and to the public.
(j) RMW must not be mixed with or come in contact with other solid waste. If the facility is authorized by the department to accept such waste, a permanent physical barrier must exist to prevent the mixing of RMW, treated RMW, TDMW and solid waste.
(k) Storage areas must protect RMW from the elements, be ventilated to the outdoors, be only accessible to authorized persons and be marked with prominent warning signs on, or adjacent to, the exterior doors or gates. The warning signs must include the nationally recognized biohazard symbol and must be easily read from a distance of 25 feet. Outside storage areas containing RMW (e.g., dumpsters, sheds, tractor trailers or other storage areas) must be locked to prevent unauthorized access.
(l) Reusable containers for RMW must be thoroughly washed and decontaminated each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by disposable liners, bags or other devices that are removed with the RMW.
(m) Reusable containers used for the storage of RMW must be disinfected before they are used for the storage or containmment of any other solid waste or for other purposes.
(n) 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.
(o) Compactors and trash chutes must not be used to process untreated RMW. Untreated RMW must not be dumped from vehicles.
(p) In addition to the requirements of sections 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 office of the department administering the 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, 625 Broadway, Albany, NY 12233-4010. The permittee or his representative must:
(1) Immediately notify by telephone the regional solid waste engineer in the office of the department administering the region in which the facility is located, if an unscheduled facility shutdown exceeds 24 hours or if the contingency plan is implemented. Within 72 hours a written report of the incident must be sent to the individuals identified in subdivision (p) of this section.
(2) Prepare and file a quarterly report, compiled on a weekly basis, on a form prescribed by or acceptable to the department. Copies of the report must be received by individuals identified in subdivision (p) of this section within 30 days after the end of each quarter. Reports must include copies of operating information, such as receipt and disposition of RMW 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 prescribed by or acceptable to the department, no later than 60 calendar days after the first day of January of each year of operation. The annual report must be sent to the individuals identified in subdivision (p) of this section.
(a) RMW shall not be disposed of by burial at a disposal facility unless treated in accordance with Subpart 360-17 of this Part or 10 NYCRR Part 70.
(b) RMW consisting of recognizable body parts must be disposed of by interment or treated by incineration in accordance with Subpart 360-3 and the operation plan of section 360-17.3 of this Part.
(c) RMW consisting of animal carcasses known to be exposed to infectious agents must be disposed of by interment at a New York State Department of State-approved facility or treated by incineration in accordance with Subpart 360-3 and the operation plan of section 360-17.3 of this Part. Alternative methods of disposal are acceptable if approved in writing by the commissioner of the DOH as required by paragraph 27-1507.1(d) of the ECL. Animal carcasses not known to be contaminated with infectious agents are considered solid waste and may be disposed of at a department-approved solid waste landfill, a rendering facility or other means as approved by the department.
(d) Treated RMW and TDMW from a department-approved facility or a treatment facility approved in writing by DOH, may be disposed of only at a solid waste landfill or incinerator approved in writing by the department to accept that waste. The treated RMW and TDMW must have been treated in accordance with the facility's approved operation plan and must be accompanied by a completed certification form in accordance with subdivision 360-17.4(g) of this Part. No solid waste landfill or incinerator may accept treated RMW or TDMW unless the treatment process has been approved in writing by the department or the DOH. Treated RMW received by the facility must be packaged, labeled and transported in accordance with section 364.9 of this Title.
(e) RMW consisting of sharps, as defined in section 360-17.2(h)(1)(iv) and (x), must be treated and destroyed prior to disposal in an approved landfill. Incineration of sharps, in accordance with Subpart 360-3 and the operation plan set forth in section 360-17.3 of this Part, includes both treatment and destruction.