S.C. Code Regs. § 61-105.U

Current through Register Vol. 48, No. 34, August 23, 2024
Section 61-105.U - Infectious Waste Treatment Facility Standards
(1) No person may operate an infectious waste treatment or disposal facility or generator facility without first obtaining a permit as required by this regulation except as exempted in section T. A separate permit shall be required for each site or facility although the Department may include one or more different types of facilities in a single permit if the facilities are collocated on the same site.
(2) All treatment facilities must treat the waste as indicated in Section T.
(3) Infectious waste treatment residue must not be disposed of until or unless Department approved monitoring methods confirm effectiveness of the treatment process.
(4) All treatment facilities must develop and submit to the Department for approval a standard operating procedure manual which will include at a minimum:
(a) unloading and handling procedures;
(b) safety procedures;
(c) emergency preparedness and response plans;
(d) receiving, record keeping, and reporting procedures;
(e) remedial action plans;
(f) quality assurance plans for treatment methods;
(g) radiological and hazardous waste monitoring procedures;
(h) procedures for identifying types and quantities of infectious waste received;
(i) contingency plans for use of alternate facilities; and
(j) procedures for disposition of treatment residues.
(5) Approval for acceptance of infectious waste at a treatment or disposal facility may be withdrawn by the Department for noncompliance with the standard operating procedure manual.
(6) When a facility ceases infectious waste management activities, it shall notify the Department in writing, immediately, and it shall thoroughly clean and disinfect the facility and all equipment used in the handling of infectious waste. All untreated waste shall be disposed of in accordance with the requirements of this regulation.
(7) In the event of an accidental spill of infectious waste the designated personnel at the facility shall:
(a) contain the spill to the area immediately affected;
(b) immediately disinfect the area which is contaminated;
(c) pick up, repackage as required or otherwise immediately remove the spilled material into the treatment system;
(d) record the incident in a bound log book, including the quantity spilled, personnel involved, and the nature and consequences of the event; and
(e) It is unlawful for any person to discharge infectious waste or treatment residue into the environment of this State except as permitted by the Department. If a release of infectious waste or treatment residue to the environment is known or suspected, the facility must report to the Department within twenty-four (24) hours and immediately investigate and confirm all suspected releases. Action may then be required by local, state, or federal officials so that the infectious waste or treatment residue discharge no longer presents an actual or potential hazard to human health or the environment.
(8) All individuals involved with handling and management of waste shall receive thorough training in their responsibilities and duties. A training protocol shall be submitted to the Department at the time of application for a permit. Training documentation for individuals shall be submitted to the Department within thirty (30) days of completion.
(9) Permittees shall notify the Department in writing within thirty (30) days prior to any changes in ownership, operating control, name, or location. The Department may upon written request transfer a permit to a new owner or operator where no other change in the permit is necessary provided that a written agreement containing a specific date for transfer of permit responsibility and financial assurance between the current and new owner has been submitted to the Department.
(10) A facility receiving waste generated in a hospital or other generator which uses radioactive material must screen incoming waste for radioactivity as they arrive at the treatment facility. Such facilities must:
(a) use instrumentation which is approved by the Department for this purpose;
(b) have the operator properly trained on such equipment;
(c) have such equipment calibrated at least once a year by an authorized calibrator;
(d) maintain a log of quality assurance testing and calibration of such instrumentation; and
(e) report any and all incidents when radioactive materials are detected to the Department for guidance in dealing with the radioactive materials. The Department may allow a treatment facility to hold containers of waste containing radioactive material for radioactive decay after the facility has submitted procedures for appropriately managing the containers and has received approval from the Department. However, under no circumstance may a treatment facility solicit the receipt of radioactive material.
(11) Facilities shall schedule shipments of waste to prevent a backlog of loaded transportation vehicles at the facility or offsite. The number of loaded and unloaded transport vehicles stored onsite will be controlled by permit conditions.
(12) A facility receiving waste generated offsite must log-in transport vehicles as they arrive at the facility in a bound log book and note in this book if any shipments are rejected. The treatment facility must:
(a) disinfect the cargo-carrying compartment(s) immediately after unloading the waste; and
(b) clean out visible debris and immediately put debris into the treatment system.
(13) Incinerators must, in addition to items (1) through (12) above:
(a) provide complete combustion of the waste and packaging to carbonized or mineralized ash;
(b) comply with all applicable regulations issued by the Department; and
(c) receive authorization for disposal of treatment residue from the Department prior to disposition into a landfill located in this state, and said authorization shall be based on relevant analyses and requirements deemed necessary by the Department. Such authorization may be incorporated into a landfill permit.
(14) All steam sterilizers must, in addition to items (1) through (12) above.
(a) use Department approved indicator organisms in test runs to assure proper treatment of the waste. Indicator organisms must be used daily at a commercial facility and monthly at a generator facility in each steam sterilizer;
(b) record the temperature and time during each complete cycle to ensure the attainment of a temperature of 121 degrees Centigrade (250 degrees Fahrenheit) for 45 minutes or longer at fifteen (15) pounds pressure, depending on quantity and density of the load, in order to achieve sterilization of the entire load; (Thermometers shall be checked for calibration at least annually.)
(c) have a gauge which indicates the pressure of each cycle;
(d) use heat sensitive tape or other device for each container that is processed to indicate that the steam sterilization temperature has been reached. The waste will not be considered appropriately treated if the indicator fails;
(e) use the biological indicator Bacillus stearothermophillus placed at the center of a load processed under standard operating conditions to confirm the attainment of adequate sterilization conditions;
(f) maintain records of the procedures specified in (b), and (e) above for period of not less than three (3) years; and
(g) assure that treatment residues are disposed of in accordance with applicable State and Federal requirements.

S.C. Code Regs. 61-105.U