Part IV. Standards for Regulated Medical Waste Transfer Stations and Treatment Facilities
9VAC20-121-200. General and applicability.
A. Any person who designs, constructs, or operates any regulated medical waste transfer station or treatment facility not otherwise exempt under 9VAC20-121-300 E shall obtain a permit-by-rule pursuant to this chapter prior to operation and comply with the requirements of this part. Further, all applications pursuant to this chapter shall demonstrate specific means proposed for compliance with requirements set forth in this part.
B. All facilities, except exempted facilities, shall be maintained and operated in accordance with the permit-by-rule status pursuant to this chapter. All facilities shall be maintained and operated in accordance with the approved design and intended use of the facility.
C. Hazardous wastes shall not be managed or disposed in facilities subject to this regulation unless specifically authorized by the facility permit or the director and managed in accordance with 9VAC20-60. Any material from a state other than Virginia that is classified as a hazardous waste in that state shall be managed as hazardous waste in accordance with 9VAC20-60.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-210. Siting requirements.
A. The siting of all regulated medical waste transfer stations or treatment facilities shall be governed by the standards as set forth in this section. These facilities shall:
1. Be adjacent to or have direct access to roads that are paved or surfaced and capable of withstanding anticipated load limits;
2. Not be sited or constructed in areas subject to base floods;
3. Shall not be closer than:
a. 50 feet to any property boundary;
b. 50 feet to any perennial stream or river;
c. 200 feet to any residence or recreational park area; or
d. 200 feet to any health care facility, school, or similar type public institution, unless the facility is located at the health care facility, school, or similar type public institution.
B. The site of a regulated medical waste transfer station or treatment facility shall provide room to minimize traffic congestion and allow for safe management of regulated medical waste and safe operation of the facility.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-220. Design and construction requirements.
A. The design and construction of all regulated medical waste transfer stations or treatment facilities shall be governed by the standards as set forth in this section. These facilities shall have:
1. An access road suitable for loaded collection vehicles in all weather conditions from the entrance to the unloading or receiving area of the facility.
2. Onsite queuing capacity for the expected traffic so that the waiting collection vehicles do not back up onto the public road.
3. Unloading and loading areas of an adequate size and design to facilitate efficient transfer of regulated medical waste to and from collection vehicles and the unobstructed movement of vehicles.
4. Access controls such as perimeter security fencing, gates, locks, badge systems, or other controls to limit access to areas used to store, transfer, or treat regulated medical waste to only those persons specifically designated to manage regulated medical waste.
5. Adequate lighting so that operating personnel can exercise site control. Lighting may be provided by portable equipment as necessary.
6. Covered areas with cleanable and impermeable surfaces for handling, storage, transfer, and treatment of regulated medical waste and the cleaning and disinfection of reusable containers. These areas shall not be carpeted or have floor coverings with cracks or gaps. Where tile floors are used and seams are present in the tile, the floor must be sealed with wax or other floor coatings in order to meet this requirement.
7. Bermed pavement, a liquid retaining lip, or equivalent controls at loading docks and near rolling or bay doors to contain potential leaks and spills of regulated medical waste or other liquids.
8. Floors sloped or graded to drain such that all effluent, wash water, and other runoff from storage and processing areas, treatment equipment, waste compactors, and reusable container cleaning and disinfection areas is contained and discharged directly to an approved sanitary sewer system.
9. Ventilation that discharges to minimize human exposure to the waste.
10. A water supply shall be provided for cleaning purposes.
11. Fire alarm and protection systems capable of detecting, controlling, and extinguishing any and all fires.
12. Fixed radiation detectors in a location as close as practicable to the incoming waste loads and in an appropriate geometry to monitor all waste prior to storage, transfer, or treatment. A fixed radiation detector is not required at captive regulated medical waste management facility if the facility demonstrates that there is no potential for generation or management of radioactive materials or wastes. Demonstration shall include a certification that there is no radiation producing equipment or material onsite.
B. Effluent, wash water, and other runoff from the facility shall not be permitted to drain or discharge into surface waters except when authorized under a VPDES permit issued pursuant to 9VAC25-31.
C. Slides, cart tippers, conveyors, and similar equipment used to move regulated medical waste must be designed and constructed such that the movement and impact is controlled to maintain the integrity of the packaging at all times and prevent damage, leakage, and spills. Trash chutes shall not be used to manage regulated medical waste.
D. Any areas used for the storage of regulated medical waste shall be designed in accordance with 9VAC20-121-120 and have sufficient storage capacity for the maximum anticipated storage amount based on the amount of daily incoming waste and maximum length of time in storage.
E. All facilities that manage reusable containers or carts for regulated medical waste shall have designated areas for manual or mechanical cleaning and disinfection that comply with the requirements of 9VAC20-121-130.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-230. Operation requirements.
A. The operation of regulated medical waste transfer stations or treatment facilities shall be governed by the standards as set forth in this section.
B. The regulated medical waste transfer station or treatment facility shall maintain and operate in accordance with a regulated medical waste management plan that meets all requirements of 9VAC20-121-330. This plan shall be reviewed and recertified annually, within one year from the date of the last certification, to ensure consistency with current operations and regulatory requirements, and shall be made available for review by the department upon request. If the applicable standards of this chapter and the facility's operations plan conflict, this chapter shall take precedence.
C. The facility must operate to comply with the general handling requirements of 9VAC20-121-100.
D. All regulated medical waste shall be packaged, labeled in accordance with 9VAC20-121-110 and managed in accordance with the storage conditions and timeframes required by 9VAC20-121-120. The facility shall employ methods to track and document specific incoming waste throughout the duration of storage, treatment or transfer, and shipment offsite.
E. All facilities that manage reusable carts or containers for regulated medical waste shall comply with the requirements of 9VAC20-121-130 and maintain onsite an adequate water supply and sufficient quantity of detergent and EPA-registered disinfectant or other approved materials, as applicable.
F. Except for reusable containers authorized by the department to be opened, regulated medical waste containers must not be opened or unpackaged unless approved as part of the consolidation or treatment process.
G. The facility shall immediately address all spills of regulated medical waste, incidents or emergencies, maintenance events, and nonconformances that could have an impact on the management of regulated medical waste. Spill containment and cleanup kits shall be maintained as required by 9VAC20-121-140 B, and immediately following a spill of regulated medical waste or its discovery, the procedures specified in 9VAC20-121-140 C shall be implemented.
H. Damaged or leaking packages of regulated medical waste shall either be properly repackaged prior to storage and subsequent shipment offsite or contained and treated onsite within 24 hours if the facility is permitted for treatment operations.
I. Transportation of regulated medical waste is subject to the requirements of 9VAC20-121-150.
J. Waste must not be accepted unless it is allowed in accordance with the permit-by-rule issued and the regulated medical waste management plan and there is sufficient storage, transfer, or treatment capacity. The amount of regulated medical waste received and stored at the facility shall not exceed the permit process rate and designed storage capacity.
K. Regulated medical waste transfer stations and treatment facilities regulated under this part shall implement an unauthorized waste control program in accordance with their written plan as required by 9VAC20-121-330 and the following provisions:
1. Prior to managing regulated medical waste or using process equipment, and at least annually, within one year from the date of the last training, the facility shall provide training to staff to recognize, segregate, properly manage, document, and report receipt of waste not authorized to be managed by the facility's permit.
2. If unauthorized waste is observed in the waste delivered to the facility prior to unloading, the owner or operator must refuse to accept the waste.
3. If the unauthorized waste is observed in the waste at the facility or delivered to the facility, the owner or operator shall segregate it, notify the generator (if applicable), document the incident in the operating record, make necessary arrangements to have the material managed in accordance with applicable federal and state laws, and notify the department of the incident to include the means of proper handling, in accordance with the reporting procedures of 9VAC20-121-340.
4. Any unauthorized waste accepted by the owner or operator shall be managed in accordance with applicable federal or state laws and regulations. The facility must carefully store the waste in a designated storage area within the facility separate from untreated regulated medical waste and treated regulated medical waste. Unauthorized waste that has been segregated and stored shall be adequately secured and contained to prevent leakage or contamination to the environment. The facility shall have the unauthorized waste removed or properly managed no later than 10 calendar days after discovery unless an alternate timeframe up to 30 days is approved by the department . Handling and management of the unauthorized waste, including segregation, removal, and transportation, shall be by a person authorized to manage such waste and shall be transferred, treated, or disposed of at a permitted waste management facility approved to receive it.
5. The facility must maintain a record of all unauthorized waste accepted at the facility, the date accepted, the type of waste, date of transfer, treatment, or disposal, management method, and the name, address, and telephone number of the final treatment or disposal facility.
L. Radiation detection equipment shall be operated and maintained in a manner that ensures all incoming waste is screened and the measurements are meaningful and fulfill the objectives for detecting radiologically contaminated waste. If fixed radiation detectors become inoperable, repairs shall be made as soon as practicable, and appropriate portable equipment shall be used to screen incoming waste loads until the equipment is repaired.
M. Untreated waste, radioactive waste, hazardous waste, and any unauthorized waste must be segregated and stored in clearly identified containers. Category A waste shall be managed in accordance with the requirements of 9VAC20-121-160.
N. The facility shall be operated to maintain the design and construction standards as required by 9VAC20-121-220.
O. All areas used to transfer or treat regulated medical waste shall have prominent signage or markings displayed on the door or access point to indicate that the space is used to manage regulated medical waste, and those areas shall be secured to prevent unauthorized access.
P. Floors and areas used for the handling, tipping, storage, transfer, or treatment of regulated medical waste and reusable container cleaning must be kept clean, in an orderly condition, and free of standing liquid and debris.
Q. Effluent, wash water, and other runoff from facility floors, storage and processing areas, treatment equipment, waste compactors, and reusable container cleaning and disinfection areas shall be contained and discharged directly to an approved sanitary sewer system. Effluent, wash water, and other runoff from the facility shall not be permitted to drain or discharge into surface waters except when authorized under a VPDES permit issued pursuant to 9VAC25-31.
R. All infrastructure and equipment shall be properly maintained and operated as designed and approved in the facility's permit. Facility maintenance must include annual calibrations of parametric controls, including recording devices and temperature and pressure gauges; overall cleaning (the facility, vehicles, and processing systems); servicing of exhaust lines and drains; ensuring the proper functioning of pressure and safety valves, and water, steam, disinfectant and electrical lines; replacing gaskets as needed to ensure a complete seal at all times; ensuring floor drains are maintained such that liquid is free-draining at all times; and maintaining proper functioning of mechanical waste handling systems, conveyors and shredders, HEPA, and other ventilation and filtration devices, and radiation monitoring devices, as applicable.
S. Adequate numbers and types of properly maintained equipment shall be available for operation. Provision shall be made for substitute equipment to be available, except for treatment units which must be approved by the department, or the emergency contingency plan implemented to achieve compliance with this chapter, as applicable, within 24 hours should the former become inoperable or unavailable. Operators with training appropriate to the tasks they are expected to perform and in sufficient numbers for the complexity of the site shall be on the site whenever it is in operation.
T. Safety hazards to operating personnel shall be controlled through an active safety program consistent with the requirements of 29 CFR Part 1910, as amended.
U. Each facility shall conduct monthly inspections of all major aspects of facility operations necessary to ensure compliance with the requirements of this chapter. Records of these inspections must be maintained in the operating record and available for review in accordance with 9VAC20-121-340. If a deficiency or release is identified during an inspection, the owner or operator must document it on the self-inspection checklist, provide a remedy for the issue as soon as feasible, and document repairs and remedial actions, including the date implemented. The following aspects of the facility shall be inspected on a monthly basis whenever the facility is in operation:
1. Each component of the processing equipment, treatment system, and infrastructure;
2. Spill containment and cleanup kit and any other decontamination materials;
3. Safety and emergency equipment, including radiation detection equipment, fire alarm and protection systems, fire extinguishers, eyewash stations, or other equipment;
4. Waste storage areas and loading and unloading areas;
5. All floors and floor drains and any areas and inventory for managing, cleaning, and disinfecting reusable carts or containers;
6. Proper use of personal protective equipment by all employees;
7. Monitoring for pests and vermin, litter, blowing debris, odor, dust, breached containers, and spills; and
8. Any areas in which significant adverse environmental or health consequences may result if breakdown occurs.
V. Prior to managing regulated medical waste or using process equipment, and at least annually, within one year from the date of the last training, the facility shall provide all operators with training on the procedures for managing regulated medical waste specific to the transfer or treatment process used, including:
1. General handling of regulated medical waste and use of personal protective equipment;
2. Packaging, labeling, and storage of regulated medical waste;
3. Cleaning and disinfection of reusable containers;
4. Facility housekeeping and management of spills;
5. Overall process and mechanical operation of any equipment used ;
6. Emergency contingency plan procedures, in case of system failure or other emergency ; and
7. In addition to the requirements of subdivisions 1 through 6 of this subsection, treatment facility operators shall be trained on the operation of any treatment units and procedures for conducting periodic challenge testing.
W. The facility shall retain records in accordance with 9VAC20-121-340. Records shall be retained for three years and available for review as requested by the department.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-240. Treatment standards.
A. Prior to disposal or recycling, all regulated medical waste, including its packaging, must be treated by a department approved regulated medical waste treatment process. Any method used for the treatment of regulated medical waste must be verifiable to render the waste noninfectious in a manner that is protective of human health and the environment. Untreated regulated medical waste shall not be recycled or disposed of in a solid waste landfill or other solid waste management facility.
B. The requirements in this subsection are applicable to all treatment methods. Additional requirements are provided in subsections C through I of this section and are dependent on the type of treatment used.
1. The treatment method and operating parameters shall be appropriate and effective for the type of waste being managed.
a. Human pathological and anatomical waste, including tissues, organs, body parts, and other related waste and animal carcasses shall be treated by incineration unless an alternative treatment process is approved by the department. Alkaline hydrolysis is an alternative treatment process that may be considered for treatment. Pathological waste in a liquid fixative may require special management, such as decanting the liquid for separate disposal, incineration, or management as hazardous waste if applicable.
b. Thermally resistant waste, including solidified liquids and bulk animal bedding, requires approval of treatment operating parameters on a case-by-case basis.
c. Category A waste shall be managed in accordance with the requirements of 9VAC20-121-160.
d. Waste contaminated with toxins and toxin waste solutions (depending on the toxin) can be inactivated by incineration or extensive autoclaving, or by soaking in suitable decontamination solutions. Toxin inactivation procedures shall not be assumed to be 100% effective without validation using specific toxin bioassays.
2. Treatment equipment shall include built-in automatic controls and fail safe mechanisms to ensure the waste cannot bypass the treatment process.
3. Size reduction, grinding, shredding, or puncturing of containers is permissible if integral to the treatment unit and shall be done with safe and sanitary methods. Nothing in this section shall prevent the use of devices that grind, shred, or compact to reduce volume at the point of generation and prior to enclosing the regulated medical waste in plastic bags and other required packaging; however, the waste remains regulated medical waste. The facility shall demonstrate that devices are constructed and operated in a manner that prevents employee exposure to the waste; contains any aerosol, bioaerosol, or mist caused by the process; and treats or filters any air evacuated from the chamber during processing. Appropriate means must be employed to appropriately protect workers and contain the waste when unloading regulated medical wastes from such a device.
4. If grinding, shredding, or size reduction or puncturing of packaging takes place prior to treatment, it shall occur in a closed unit immediately preceding the treatment unit. If grinding, shredding, or size reduction takes place following treatment, it must occur within 24 hours of leaving the treatment unit. Transfer from a grinder or shredder to or from a treatment unit shall be under forced draft ventilation that removes fumes from the operations area to a safe discharge.
5. All process units for the preparation or treatment of regulated medical waste shall be in closed vessels designed to operate under a negative pressure atmospheric control that filters all vents, discharges, and fugitive emissions of air from the process units through a high efficiency particulate air (HEPA) filter with efficiency of 99.97% for 0.3 microns. Proper installation of filters shall be documented. Air and gases which have themselves been sterilized by the process are not required to pass through a filter.
6. All effluent must be discharged to an approved sanitary sewer system. Effluent from the facility shall not be permitted to drain or discharge into surface waters except when authorized under a VPDES permit issued pursuant to 9VAC25-31.
7. Only the types of regulated medical waste specified in the facility's permit shall be treated using the approved treatment unit. Treatment methods include:
a. Autoclaves (steam sterilization);
b. Microwaves;
c. Dry heat treatment;
d. Chemical treatment;
e. Alkaline hydrolysis;
f. Incineration; and
g. Alternate treatment technologies as reviewed and approved by the department in accordance with this chapter.
8. Prior to operation of any treatment unit, the facility must conduct validation testing in accordance with 9VAC20-121-260 and an approved treatment plan to establish the appropriate operating parameters for effective treatment of regulated medical waste. The results of the testing must be submitted to the department for review and approval in accordance with 9VAC20-121-320. The facility shall not receive or treat regulated medical waste until the department has approved the validation results, operating parameters, and protocols to be used for the treatment unit. Revalidation shall be conducted as required by 9VAC20-121-260.
9. Treatment units shall operate in accordance with the specified operating parameters and protocols set forth in subsections C through I of this section or alternate standards established through validation testing and approved by the department. Records of treatment shall be maintained in accordance with 9VAC20-121-340.
10. Periodic challenge testing shall be performed under full loading in accordance with 9VAC20-121-270 to evaluate the effectiveness of each treatment unit and treatment method.
11. Effective treatment of regulated medical waste must achieve a 6 Log10 or greater reduction of the viable spore concentrations of the most appropriate bacterial species for the treatment method. Effective treatment is demonstrated by no growth in all treated biological indicators and growth in all untreated biological indicators during validation and periodic challenge testing.
12. The selection of the most appropriate biological indicator to utilize during validation and challenge testing of a treatment process shall be supported by referenced standards, guidelines, or information from peer reviewed journals related to the process.
a. Biological indicators shall utilize spores from one of the following bacterial species:
(1) Geobacillus stearothermophilus (G.s.);
(2) Bacillus atrophaeus (B.a.);
(3) Bacillus subtilis (B.s.);
(4) Other Bacillus species or spore forming bacteria from domestic or international culture collections; or
(5) Organisms that demonstrate the necessary resistance for the treatment method, as approved by the department.
b. The facility shall use commercially prepared biological indicators, such as spore strips, spore suspensions, and self-contained biological indicators.
c. Biological indicators shall be placed in the most challenging location during validation and periodic challenge testing. Indicator ports, chambers, or other mechanisms shall be used for placement of the biological indicator when placement directly into the waste may be compromised by the treatment method, such as when shredding, grinding, or other mechanism is used. Ports and chambers shall be accessible by the operator.
d. When using the appropriate biological indicator, the number to be used shall be based upon the amount of waste to be processed in accordance with 9VAC20-121-260 D 7 (for validation) and 9VAC20-121-270 B (for periodic challenge testing).
13. Parametric controls shall be used to monitor critical operational treatment parameters and provide a record of measurements that can be correlated to effective treatment.
14. Door alignment, gaskets, locking mechanisms, and other components of any treatment unit that utilizes a pressure vessel (such as an autoclave) shall achieve a complete seal during operation to prevent leaking of steam, liquid, or waste and avoid decreases in pressure or temperature that could cause isolated cold spots inside the unit.
15. In the event of power failure, interrupted, or incomplete treatment cycle, the facility shall investigate the cause of the failure and make any necessary repairs to resolve the issue prior to the next treatment cycle. Any waste in the treatment unit shall either be removed and managed as regulated medical waste or subjected to another full treatment cycle once repairs are made.
16. After each cycle, treated waste shall be removed from reusable treatment carts and containers. All reusable treatment carts and containers shall be cleaned on a periodic basis to remove the buildup of more than de minimis amounts of treated waste residual on cart and container surfaces.
C. The requirements in this subsection are applicable to autoclave treatment methods.
1. All autoclaves shall be operated at 100% saturated steam conditions at appropriate combinations of operating temperatures, pressures, and residence times, that have been demonstrated through validation testing to achieve reliable and effective treatment of microorganisms in regulated medical waste at design capacity. Longer treatment cycles may be needed for loads with liquids. Autoclave operating temperatures shall be greater than or equal to 250oF (121oC) at no less than 15 pounds per square inch of gauge pressure, and the minimum operating temperature and pressure shall be maintained during the residence time of the treatment cycle.
2. All autoclaves shall be equipped with continuous time, temperature, and pressure monitoring and recording.
3. For vacuum autoclaves, pre-vacuum shall be conducted such that all system air is fully evacuated a minimum of two times prior to the residence phase of the treatment cycle , during which all air is evacuated to ensure adequate steam exposure throughout the waste. Additional pre-vacuum pulls may be required based on certain waste or packaging types, and as determined through validation testing.
4. For gravity autoclaves, pressure pulsing must be performed to evacuate all air in the unit.
5. Validation and periodic challenge testing shall be performed using biological indicators utilizing spores from the bacterial species Geobacillus stearothermophilus.
D. The requirements in this subsection are applicable to microwave treatment methods.
1. Microwaving treatment shall incorporate pretreatment by shredding and steam injection or induction.
2. All microwaves shall be operated between 203oF and 212oF (95oC and 100oC) for a minimum of 45 minutes. Alternate operating temperatures and cycle times may be demonstrated through validation testing.
3. Microwave radiation power of the treatment process shall be at least six units each having a power of 1,200 watts or the equivalent power output.
4. Each microwave treatment unit shall be equipped to sense, display, and continuously record the temperature at the start, middle, and end of the treatment chamber.
5. Process temperatures at the exposure chamber entry and exit and the waste flow rate shall be continuously monitored, displayed, and recorded.
6. Validation and periodic challenge testing shall be performed using biological indicators utilizing spores from the bacterial species Bacillus atrophaeus.
E. The requirements in this subsection are applicable to dry heat treatment methods.
1. Dry heat systems shall be operated per the following operational standards:
a. Temperature of not less than 320oF (160°C) for 120 minutes;
b. Temperature of not less than 340oF (170°C) for 60 minutes; or
c. Temperature of not less than 360oF (180°C) for 30 minutes.
Alternate operating temperatures and cycle times may be demonstrated through validation testing.
2. Each treatment unit shall be equipped to sense, display, and continuously record the temperature of the treatment chamber.
3. Unless otherwise approved by the department, no treatment unit employing dry heat as the main treatment process shall have a treatment chamber capacity greater than 1.0 cubic foot in volume.
4. Validation and periodic challenge testing shall be performed using biological indicators utilizing spores from the bacterial species Bacillus atrophaeus.
F. The requirements in this subsection are applicable to chemical treatment methods.
1. Operating standards for chemical treatment systems are dependent on the chemical concentration and exposure time. Facilities wishing to employ a chemical treatment system shall submit an alternate treatment technology petition per 9VAC20-121-250 to justify the proposed operating parameters. Once the petition is approved, chemical concentration and treatment time operating parameters shall be demonstrated through validation testing in the presence of the maximum anticipated organic waste content.
2. The facility shall maintain registration for the chemical used in the treatment system in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act, if required.
3. Containers holding chemicals shall be labeled in accordance with 40 CFR 156 (Labeling Requirements for Pesticides and Devices), and the facility shall maintain Safety Data Sheets for all chemicals related to the chemical treatment system.
4. Validation and periodic challenge testing shall be performed using biological indicators utilizing spores from the bacterial species Bacillus subtilis or Bacillus atropheus.
G. The requirements in this subsection are applicable to alkaline hydrolysis treatment methods. Alkaline hydrolysis is a process by which heat and pressure dissolve and sterilize regulated medical waste in a strong solution of sodium or potassium hydroxide (NaOH or KOH, respectively).
1. Alkaline hydrolysis shall only be used for treatment of human pathological and anatomical waste, including tissues, organs, body parts, other related waste, and animal carcasses.
2. Systems that operate above atmospheric pressure must employ a dissolution chamber that is a certified pressure vessel by the American Society of Mechanical Engineers (ASME).
3. Operating parameters for alkaline hydrolysis systems vary depending on the amount of regulated medical waste to be treated and the type of contamination:
a. To inactivate microbial pathogens, the waste must be heated to 212oF (100oC), and pressurized at 15 pounds per square inch for three hours;
b. To destroy transmissible spongiform encephalopathy (TSE), including bovine spongiform encephalopathy, the waste must be heated to 300oF (150oC) and pressurized at 70 pounds per square inch for six to eight hours.
c. Chemical concentration and treatment time shall be demonstrated through validation testing in the presence of the worst case organic material waste content.
4. Treatment shall ensure the complete dissolution of all tissue remains, if applicable, and any solids left shall be disposed of at a solid waste management facility permitted to receive it.
5. Validation and periodic challenge testing shall be performed using biological indicators utilizing spores from the bacterial species Geobacillus stearothermophilus.
H. The requirements in this subsection are applicable to incineration treatment methods.
1. All incinerators shall be permitted under regulations of the State Air Pollution Control Board and be in compliance with the regulations of that body.
2. All combustible regulated medical waste shall be converted by the incineration process into ash that is not recognizable as to its former character.
3. Analysis of ash and air pollution control residues:
a. Incinerator bottom ash and residues collected from air pollution control equipment shall be collected separately in leak resistant containers with runoff controls to prevent releases from the ash storage. Incinerator bottom ash and air pollution control residues shall be stored separately until sample testing per subdivision 3 b of this subsection is performed and the waste streams are determined to be a solid waste.
b. Testing requirements:
(1) Representative samples consisting of 250 milliliters of each waste stream shall be collected once every eight hours of operation of a continuously fed incinerator and once every batch or 24 hours of operation of a batch fed incinerator. Samples shall be collected during each 1,000 hours of operation or quarterly, whichever is more often, and samples shall be thoroughly mixed and seven random portions of equal volume shall be composited into one sample for laboratory analysis. This sample shall be tested in accordance with the methods established by the Virginia Hazardous Waste Management Regulations (9VAC20-60) for determining if a solid waste is a hazardous waste.
(2) In addition to subdivision 3 b (1) of this subsection, composite samples of incinerator bottom ash shall be tested for total organic content.
c. If ash or air pollution control residues are found to be hazardous waste (based on a sample and a confirmation sample) the waste ash shall be managed of as a hazardous waste in accord with the Virginia Hazardous Waste Management Regulations (9VAC20-60). The operator shall notify the department within 24 hours. No later than 15 calendar days following, the permittee shall submit a plan for treating and disposing of the waste on hand at the facility and all unsatisfactorily treated waste that has left the facility. The permittee shall include with the plan a description of the corrective actions to be taken to prevent further unsatisfactory performance. No ash or air pollution control residues subsequently generated from the incinerator waste stream found to be hazardous waste shall be sent to a nonhazardous solid waste management facility in the Commonwealth unless written approval of the director is obtained in accordance with Solid Waste Management Regulations (9VAC20-81).
d. If ash or air pollution control residues are found not to be hazardous waste by analysis, they may be disposed of in a solid waste landfill that is permitted to receive municipal solid waste or incinerator ash, provided the disposal is in accordance with the Solid Waste Management Regulations (9VAC20-81).
e. A log shall document the ash sampling, to include the date and time of each sample collected; the date, time, and identification number of each composite sample; and the results of the analyses, including laboratory identification. Results of analyses must be returned from the laboratory and recorded within four weeks following collection of the composite sample. The results and records described in this part shall be maintained for a period of three years, and shall be available for review.
I. Alternate treatment technologies as reviewed and approved by the department. All alternate treatment technologies approved by the director shall conform to the general treatment standards in subsection B of this section and any additional requirements the department imposes at the time of approval.
1. Any person who desires to use a chemical treatment technology per subsection F of this section or treatment technology, other than those described in subsections C, D, and E or subsections G and H of this section, shall petition the director for a review under 9VAC20-121-250.
2. If the director finds that the technology and application is in accordance with this part, the department may consider the facility for permitting.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-250. Alternate treatment technologies.
A. In accordance with 9VAC20-121-240 I, chemical treatment and other alternate treatment technologies may be approved for permitting if the department reviews the process and determines that the technology provides treatment in accordance with this chapter and protects public health and the environment, and if the department establishes appropriate conditions for their siting, design, and operation. This section establishes the criteria, protocols, procedures, and processes to be used to petition the director for review and to demonstrate the suitability of the proposed technology for the treatment of regulated medical waste.
B. Alternate treatment technologies are subject to the general treatment standards of 9VAC20-121-240 and the additional requirements of this section. To ensure effectiveness of the proposed chemical or alternate treatment technology, the applicant must demonstrate effective microbial and bacterial inactivation at a 6 log10 or greater reduction for the microorganisms and spores listed in subsections C and D of this section through validation testing that meets the requirements of 9VAC20-121-260.
C. Microbial inactivation shall be demonstrated using one or more representative microorganisms from each microbial group:
1. For vegetative bacteria: either Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15442).
2. For fungi: either Candida albicans (ATCC 18804), Penicillium chrysogenum (ATCC 24791), or Aspergillus niger.
3. For viruses: either Polio 2 or Polio 3, or MS-2 Bacteriophage (ATCC 15597-B1).
4. For parasites: either Cryptosporidium spp. oocysts or Giardia spp. Cysts.
5. For Mycobacteria: either Mycobacterium terrae, Mycobacterium phlei, Mycobacterium bovis (BCG) (ATCC 35743).
D. Bacterial inactivation shall be demonstrated for chemical, thermal, and irradiation treatment systems using spores from either B. stearothermophilus (ATCC 7953) or B. subtilis (ATCC 19659).
E. For those treatment processes that can maintain the integrity of the biological indicator carrier (i.e., ampules, plastic strips) of the desired microbiological test strain, biological indicators of the required strain and concentration shall be used to demonstrate effective treatment. Effective treatment is demonstrated by no growth in all treated biological indicators and growth in all untreated biological indicators during validation and periodic challenge testing.
F. For those treatment mechanisms that cannot ensure or provide integrity of the biological indicator (i.e., chemical inactivation or grinding), quantitative measurement of effective treatment requires a two-step approach: Step 1, "Control"; Step 2, "Test." The purpose of Step 1 is to account for the reduction of test microorganisms due to loss by dilution or physical entrapment.
1. Step 1 is:
a. Use microbial cultures of a predetermined concentration necessary to ensure a sufficient microbial recovery at the end of this step.
b. Add suspension to a standardized medical waste load that is to be processed under normal operating conditions without the addition of the microbial inactivation agent (i.e., heat, chemicals).
c. Collect and wash waste samples after processing to recover the biological indicator organisms in the sample.
d. Plate recovered microorganism suspensions to quantify microbial recovery. (The number of viable microorganisms recovered serves as a baseline quantity for comparison to the number of recovered microorganisms from wastes processed with the microbial inactivation agent).
e. The required number of recovered viable indicator microorganisms from Step 1 must be equal to or greater than the number of microorganisms required to demonstrate a 6 log10 or greater reduction.
2. Step 2 is:
a. Use microbial cultures of the same concentration as in Step 1.
b. Add suspension to the standardized medical waste load that is to be processed under normal operating conditions with the addition of the microbial inactivation agent.
c. Collect and wash waste samples after processing to recover the biological indicator organisms in the sample.
d. Plate recovered microorganism suspensions to quantify microbial recovery.
3. From data collected from Step 1 and Step 2, the level of microbial and bacterial inactivation shall be calculated based on the:
a. Number of viable "Test" microorganisms (in colony forming units per gram of waste solids) introduced into the treatment unit,
b. Number of "Control" microorganisms (in colony forming units per gram of waste solids) that were not recovered after processing, and
c. Number of viable "Test" microorganisms (in colony forming units per gram of waste solids) recovered in treated processed waste residue.
G. To initiate the technology review process the applicant shall complete and submit DEQ Form RMWTP-01, Application for Evaluation and Approval of Regulated Medical Waste Treatment Technology to the department. The application shall be accompanied by:
1. A detailed description of the chemical or alternate treatment technology. The description must include:
a. A discussion of operating procedures and conditions, including, as applicable, treatment times, pressure, temperatures, chemical concentrations, irradiation doses, feed rates, and waste load composition;
b. A discussion of parametric controls, verifying effective treatment, and ensuring operator noninterference; and
c. A discussion of waste residues and by-products generated and methods of disposal or recycling.
d. The description shall be accompanied by the manufacturer's operations manual or equipment usage instructions, equipment specifications, and maintenance manual.
2. Documentation demonstrating the chemical or alternate treatment technology meets microbial and bacterial inactivation criteria specified under subsections B through F of this section. The documentation must include a description of the test procedures and calculations used in fulfilling required performance standards verifying effective treatment, of user verification methodology, and of microbial culturing protocols that ensure traceability, purity and concentration, and copy of all test results.
3. A chemical management plan describing all chemicals to be stored on site and include copies of Safety Data Sheets for all chemicals used for regulated medical waste treatment and EPA pesticide registration, if applicable.
4. Documentation providing occupational safety and health assurance.
H. The applicant shall demonstrate that all required surrogate pathogens and resistant bacterial endospores are inactivated to criteria specified in subsections B through F of this section under the representative surrogate waste load compositions.
I. The applicant shall demonstrate where the relationship between effective treatment, biological indicator data, and data procured from real-time parametric monitoring devices for the treatment unit.
J. The review of the application will occur in accordance with this subsection.
1. After receiving an application that includes the information and demonstrations required in subsections A through I of this section, the department will perform an administrative review and determine whether the information received is sufficient to approve the proposed chemical or alternate treatment technology. If the information is deemed to be insufficient, the department will request that additional information be furnished.
2. The applicant may submit the additional information requested or may demonstrate that the additional information should not be required. If the department agrees that the additional information is not required, the department will determine if the application is complete.
3. After the application is deemed complete, the director may then issue a treatment technology approval. The approval shall be issued under the conditions specified in the manufacturer's instructions and equipment specifications, operating procedures, and conditions as outlined in the application, including, as applicable, treatment times, temperatures, pressure, chemical concentrations, irradiation doses, feed rates, and waste load composition. Any significant revision to these conditions will require reapplication for approval in accordance with this section.
4. Following technology approval, any facility wishing to use the approved technology to treat regulated medical waste shall apply for and obtain the necessary permits in accordance with Part V (9VAC20-121-300 et seq.).
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-260. Validation testing.
A. Prior to using any treatment system, the facility must conduct validation testing that employs the use of process controls, biological indicators, and process monitoring to establish operating parameters to demonstrate effective treatment of regulated medical waste.
B. Prior to validation testing, the owner or operator shall submit to the department a treatment plan containing the information required by 9VAC20-121-330 E. The plan shall demonstrate that the validation protocols for each treatment unit meet the standards of this section and shall indicate any additional protocols specific to the regulated medical waste to be treated, such as the use of packaging types that may affect treatment of the waste. Validation testing must be conducted in accordance with an approved treatment plan and the requirements of this section. The validation test results and operating parameters must be submitted to the department for review prior to acceptance of regulated medical waste for treatment.
C. To demonstrate reproducibility, a minimum of three separate treatment runs must be performed on three separate days, using three distinct loads, during which the department is present to witness at least one complete validation test run. All test runs shall meet the following requirements:
1. Operating parameters used during the tests must be consistent with the parameters that will be used during routine operation of the treatment process (e.g., cycle duration, temperature, pressure, chemical concentration, irradiation exposure time, or other treatment parameters as applicable).
2. Surrogate waste load composition (e.g., porosity, liquids, solids, moisture content, organic matter, thermal resistance, and type of packaging or containers) and waste load configuration (e.g., packing density and orientation) used during the tests must be consistent with the waste properties and loading process that will be used during routine operation. The surrogate waste load shall represent the most difficult waste anticipated to be treated during routine operation.
3. The weight and volume of the surrogate waste loads used during the tests must be consistent with the amount of waste that will be treated during routine operation. Validation testing must be performed at the treatment unit's full capacity unless an alternate load size is approved.
D. To assess treatment performance, the system must employ commercially-prepared biological indicators from the same lot or batch, each containing spores that demonstrate the necessary resistance for the treatment method, as determined by the department. The indicators must:
1. Have a minimum concentration of 6 log10 spores per biological indicator. The concentration must be higher and more thermally resistant than the bioburden routinely associated with the waste;
2. Include a supplier's certificate of performance (or certificate of analysis) that identifies the organism (genus, species, strain, and population) and, for thermal treatment systems (including autoclaves), the D-value and Z-value. The D-value must be 1.5 to 3.0 minutes, unless otherwise approved by the department, and the Z-value must be no less than 50°F (10°C);
3. Be appropriate for the type of waste and device (i.e., self-contained, suspension, or spore strip), including the shelf life, the carrier material and primary packaging, the culture medium (for self-contained biological indicators) and the media, growth, and culture conditions (for non-self-contained biological indicators);
4. Be compatible with the treatment process and have a resistance relative to the temperature, pressures, conditions, chemicals, or irradiation used in the process; the infectious agents on a substrate; the type and density of the waste to be treated; and its packaging;
5. Be placed in a carrier system (e.g., net bags, wrapped in a paper towel and encased in cotton batting or inside tennis balls, socks, or alloy containers with holes in them) designed to mimic the thermal resistance of the waste before placement into the package to be treated. Materials used to hold biological indicators must be similar to the waste to be treated, provide effective protection from damage or breakage or from otherwise being compromised, be loose in the bulk of the waste, and be easily retrievable at the end of each validation test run. Indicators shall not be placed in carrier systems that would enhance treatment or produce erroneous results (such as metal containers that would conduct heat);
6. Be placed throughout the waste load during each validation test at the coldest or most challenging locations within the treatment unit, where the sum of all influences on the microorganisms results in minimal inactivation for a defined waste load;
7. Be used in accordance with the quantity specified as follows, for each test run:
a. Three biological indicators per cycle for 0 to 110 pounds of waste per load;
b. Five biological indicators per cycle for 111 to 550 pounds of waste per load;
c. Seven biological indicators per cycle for 551 to 1,100 pounds of waste per load;
d. Nine biological indicators per cycle for 1,101 to 1,650 pounds of waste per load;
e. Eleven or more biological indicators per cycle, as determined by the department, for greater than 1,650 pounds of waste per load; and
f. One or more biological indicators from the same lot or batch to be left untreated and used as a control;
8. Be stored in accordance with the manufacturer's specifications when not in use. Expired biological indicators shall not be utilized.
9. Biological indicators in the form of paper strips must not be used in devices or areas where fluids can pool or puddle around the indicator. Self-contained biological indicators with vent caps must not be used where liquids may accumulate and contaminate the indicators.
10. Qualitative or quantitative biological indicators shall be used provided the operator or vendor of the technology provides evidence from such sources as peered reviewed journals that support the use of that particular indicator. Biological indicators requiring microbial bioassay to confirm effective treatment must be quantitatively analyzed after the treatment cycle. All self-contained biological indicators used for test runs must be evaluated for growth (e.g. qualitatively analyzed for color change) following incubation in accordance with the manufacturer's instructions.
E. Concurrent with biological indicators, the process must employ devices or instrumentation that demonstrates the treatment unit is achieving critical operating parameters for effective treatment. Process monitoring shall include:
1. Thermochemical indicators (e.g., tape, paper strips, or integrators) that demonstrate that the waste has been exposed to a certain temperature or chemical concentration;
2. Thermochemical recording devices (e.g., wireless data loggers, thermocouples, or chemical monitoring probes) that are placed in or on waste packages and that provide a measurable record of actual treatment conditions of the waste . The minimum number of thermochemical recording devices to be used during each validation test shall be at least one device per treatment bin plus one additional device in the treatment chamber; and
3. Parametric controls or monitoring devices integral to the treatment system that record critical operational treatment parameters and provide a record of measurements that can be correlated to effective treatment.
F. Effective treatment of regulated medical waste must achieve a 6 log10 or greater reduction of the viable spore concentrations of the most appropriate bacterial species for the treatment method. Effective treatment is demonstrated by no growth in all treated biological indicators and growth in all untreated biological indicators during each test run. In certain situations where the waste poses a greater risk (e.g., a higher bioburden waste), the department may require a greater reduction.
G. The facility shall submit to the department for approval a summary of the validation test results demonstrating the treatment effectiveness and specifying the operating parameters based on the results of all validation test runs. The report shall describe the results of all validation test runs, including:
1. Date and time of all test runs, including the operator's name and cycle start and end times;
2. Surrogate waste load composition, configuration, and size;
3. Number, type, batch or lot number, expiration date, and placement of biological indicators, thermochemical indicators, and thermochemical recording devices; and
4. Results of all methods used to monitor operating parameters achieved throughout the treatment cycle and the accuracy of parametric monitoring devices, including copies of charts, graphs, or other read-outs from the treatment equipment and growth results of all treated indicators and untreated controls.
H. Validation testing must be repeated when any of the following occurs:
1. Failure of any treatment process to achieve operational parameters, such as time, temperature, or pressure during validation testing;
2. Failure to achieve microbial inactivation in any biological indicator during any treatment cycle during validation testing;
3. Failure of the untreated control indicator to show growth of the viable spore concentration;
4. Any modifications to any of the treatment process operational parameters, bioburden, waste mass, chemical type, concentration, irradiation or exposure time, type of waste to be treated, or mechanical or engineering changes to the treatment system from those assessed during the validation testing;
5. A failure identified in subdivision 1, 2, or 3 of this subsection during periodic challenge testing as identified by biological or process monitoring that occurs three or more times in a calendar year or during the first 30 days of actual operation;
6. A treatment device has been operational without a repeat validation for at least five years; or
7. A treatment device has not been used for at least one year.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-270. Periodic challenge testing.
A. After initial validation testing and during routine operation, a regulated medical waste treatment facility shall perform periodic challenge testing under full loading to evaluate the effectiveness of each treatment device in accordance with procedures outlined in the facility's approved treatment plan.
B. Periodic challenge testing shall be performed in accordance with the following requirements:
1. Biological indicators shall be used to periodically challenge test a load of regulated medical waste and must comply with all requirements of 9VAC20-121-260 D, with the exception of the quantity of biological indicators required under 9VAC20-121-260 D 7.
2. Periodic challenge testing must include at least one-third of the number of appropriate biological indicators that are required for the validation test, or two indicators, whichever is greater, unless otherwise determined by the department. One or more additional biological indicators from the same lot or batch shall be left untreated and used as a control.
3. The results of all periodic challenge testing shall be maintained for three years in accordance with 9VAC20-121-340 and shall include:
a. Date and time of all challenge tests, including the operator's name and cycle start and end times;
b. Number, type, batch or lot number, expiration date, and placement of biological and thermochemical indicators; and
c. Results of all methods used to monitor operating parameters achieved throughout the treatment cycle, including copies of charts, graphs, or other read-outs from the treatment equipment and growth results of all treated indicators and untreated controls.
4. Effective treatment of regulated medical waste must be demonstrated by a 6 Log10 or greater reduction of spore concentrations in all biological indicators in each periodic challenge test. A challenge test is considered a failure if any of the following occurs:
a. Failure of any treatment process to achieve operational parameters such as time, temperature, or pressure;
b. Failure to achieve microbial inactivation in any biological indicator during any treatment cycle. All biological indicators must show passing results (no growth in the viable spore concentration) after treatment or the challenge test is considered a failure; or
c. Failure of the untreated control indicator to show growth of the viable spore concentration.
C. Any regulated medical waste treated during or after a challenge test shall be stored temporarily until challenge test results are obtained. Regulated medical waste shall not be shipped offsite until the challenge test is complete and shows passing results for all biological indicators.
D. Unless otherwise approved by the department, for the first 30 days of actual operation, each treatment unit shall undergo challenge testing twice per day. The first load of each day shall be used for one of the required challenge tests.
E. Following the first 30 days of actual operation, periodic challenge testing must be conducted at a minimum of once per week or every 40 hours of operation, whichever is greater.
F. After six months of successful operation with no challenge test failures in weekly or 40- hour testing, challenge testing shall be conducted at least once per month.
G. Any challenge test failures during the first six months of actual operation shall require a return to daily challenge testing for at least 30 operating days. After the first six months of actual operation, any challenge test failure shall require a return to challenge testing once per week or every 40 hours of operation, whichever is greater.
H. Following any challenge test failure:
1. The waste shall continue to be managed as regulated medical waste and shall be retreated, stored temporarily until retreatment, or diverted to another approved facility for treatment or disposal. Regulated medical waste shall not be considered treated until a subsequent challenge test is conducted with passing results;
2. The facility shall evaluate and correct any issues with the treatment cycle and unit prior to treating any additional waste;
3. The facility shall notify the department of the failure in accordance with 9VAC20-121-340; and
4. The facility shall increase the frequency of challenge testing in accordance with subsection G of this section.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-280. Disposal of treated regulated medical waste.
A. Regulated medical waste that has been treated in accordance with this part is no longer a regulated medical waste. Treated regulated medical waste is a solid waste. Treated waste may be compacted in a closed container in a safe and sanitary manner.
B. Treated waste shall be disposed of at a permitted solid waste disposal facility in accordance with the Solid Waste Management Regulations (9VAC20-81) and the solid waste disposal facility's permit. Regulated medical waste not treated in accordance with this chapter remains a regulated medical waste and shall not be transported to, received for transport or disposal by, or disposed in any solid waste management facility.
C. Where non-bulk treatment is used, treated waste shall be placed in sealed bags or containers that allow for visible assessment of treatment, such as clear bags or bags marked with sterilization indicators. The bags shall not be red in color. Opaque bags and bags with special labels are permissible if agreed upon in writing by the solid waste management facility receiving the treated waste. Treatment cart liners that are resistant to treatment conditions (such as temperature) may be used to package treated waste. Where bulk treatment is used and the solid waste is immediately placed or compacted in closed bulk solid waste management containers that are more than 64 gallons in volume, the repackaging of the solid waste in bags is not required. Treated waste shall not be repackaged as regulated medical waste.
D. The regulated medical waste treatment facility shall have a written treated waste disposal plan that shall be provided to each permitted solid waste management facility that will transfer, store, or dispose of the treated waste. The plan shall specify and include the following:
1. A description of how the treated waste will be packaged and transported to each solid waste management facility, including the types and colors of bags or containers used, and any special labeling if applicable;
2. The type of regulated medical waste treated, treatment method, and name, address, and telephone number of the treatment facility;
3. The name, address, and telephone number of any transfer stations or other intermediate facilities or locations where the treated waste will be transferred or temporarily stored prior to transport to a permitted solid waste disposal facility ;
4. The plan shall be updated and redistributed to receiving facilities when there are changes to the treatment process or facility operation that impact the plan.
5. The facility shall maintain records of distribution of the plan to all transfer, storage, or disposal facilities that manage the treated waste.
E. If treated residuals are determined to be hazardous, then the waste must be managed in accordance with the Virginia Hazardous Waste Management Regulations (9VAC20-60).
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.
9VAC20-121-290. Closure requirements.
A. The owner or operator of a regulated medical waste management facility shall close the facility in a manner that minimizes the need for further maintenance, and controls, minimizes, or eliminates, to the extent necessary to protect human health and the environment, the post-closure escape of regulated medical waste, uncontrolled effluent, surface runoff, or waste decomposition products to the groundwater, surface water, or atmosphere.
1. When a unit that has been used for regulated medical waste management is to cease operations involving regulated medical waste, the unit and all related equipment, structures, and surfaces shall be thoroughly cleaned and disinfected. Cleaning shall be conducted with detergent and water. At a minimum, disinfection shall include using an EPA-registered hospital grade disinfectant effective against mycobacteria in accordance with manufacturer's label instructions, unless it can be demonstrated to the satisfaction of the department that an alternate EPA-registered disinfectant will be protective of human health and the environment and is appropriate for the type of regulated medical waste managed and surfaces being disinfected.
2. All regulated medical waste, materials contaminated with waste constituents, and treatment residue shall be removed and disposed of in accordance with this chapter.
B. Closure plan and modification of plan.
1. The owner or operator of a regulated medical waste management facility shall have a written closure plan that meets the requirements of 9VAC20-121-330 G.
2. The owner or operator may amend the closure plan at any time during the active life of the facility. The owner or operator shall so amend the plan any time changes in operating plans or facility design affects the closure plan. The amended closure plan shall be placed in the operating record.
3. The owner or operator shall submit to the department the amended closure plan that was placed in the operating record.
4. At least 180 days prior to beginning closure of each unit, the owner or operator shall notify the director of the intent to close.
5. The owner or operator shall provide to the department a certification that the facility has been closed in accordance with the closure plan.
C. The owner or operator shall complete closure activities in accordance with the closure plan and within six months after receiving the final volume of wastes. The director may approve a longer closure period if the owner or operator can demonstrate that the required or planned closure activities will take longer than six months to complete, and that the owner or operator has taken all steps to eliminate any significant threat to human health and the environment from the unclosed but inactive facility.
D. The owner or operator shall post one sign notifying all persons of the closing and providing a notice prohibiting further receipt of waste materials. The sign shall remain in place until closure activities are complete. Further, suitable barriers shall be installed at former accesses to prevent new waste from being delivered.
E. The department shall inspect the facility to confirm that the closure is complete and adequate in accordance with this chapter. The department shall notify the owner of a closed facility in writing if the closure is satisfactory, or if unsatisfactory, shall require any necessary construction or such other steps as may be necessary to bring unsatisfactory sites into compliance with this chapter. Notification by the department that the closure is satisfactory does not relieve the operator of responsibility for corrective action to prevent or abate problems caused by the facility.
Statutory Authority
§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.
Historical Notes
Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.