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RULE §326.71Registration Application Contents

    (A) a description of the location of the facility with respect to known or easily identifiable landmarks;

    (B) the access routes from the nearest United States or state highway to the facility; and

    (C) longitudinal and latitudinal geographic coordinates for the point of beginning of the facility boundary's metes and bounds description.

  (2) Facility access. The owner or operator shall describe how access will be controlled for the facility such as the type and location of fences or other suitable means of access control to protect the public from exposure to potential health and safety hazards, and to discourage unauthorized entry.

  (3) Buffer zones and easement protection. No solid waste unloading, storage, or processing operations shall occur within any easement, buffer zone, or right-of-way that crosses the facility. Processing equipment and storage areas shall maintain a minimum separating distance of 25 feet between the facility boundary and processing equipment, loading, unloading and storage areas. Storage units in transport vehicles are not subject to this subsection provided that the waste is stored in refrigerated units with temperatures below 45 degrees Fahrenheit. The executive director may consider alternatives to the buffer zone requirements of this subsection where the owner or operator demonstrates that the buffer zone is not feasible and affords ready access for emergency response and maintenance. The buffer zone shall not be narrower than that necessary to provide for safe passage for firefighting and other emergency vehicles. The executive director may consider alternatives to buffer zone requirements for authorized medical waste storage and processing facilities.

  (4) Flow diagrams and narrative. The owner or operator shall provide flow diagrams showing the various phases of collection, separation, processing, and disposal as applicable for the types of wastes received at the facility along with a narrative describing each phase;

(i) Waste management unit design.

  (1) The owner or operator shall provide generalized construction information or manufacturer specifications of all storage and processing units (autoclaves, incinerators, etc.) and ancillary equipment (i.e., tanks, foundations, sumps, etc.) with regard to number of units, approximate dimensions and capacities, construction materials, vents, covers, enclosures, protective coatings of surfaces, etc.

  (2) The owner or operator shall provide generalized description of construction materials for slab and subsurface supports of all storage and processing components.

  (3) The owner or operator shall provide storage and processing areas designed to control and contain spills and contaminated water from leaving the facility. The design shall be sufficient to control and contain a worst case spill or release. Unenclosed containment areas shall also account for precipitation from a 25-year, 24-hour storm.

  (4) The owner or operator shall acknowledge that the storage of medical waste must be in a secure manner and in a location that affords protection from theft, vandalism, inadvertent human or animal exposure, rain, water, and wind. The waste must be managed so as not to provide a breeding place or food for insects or rodents, and not generate noxious odors.

  (5) For putrescible or biohazardous untreated medical waste, maintaining a temperature of 45 degrees Fahrenheit or less during pre-collection storage is optional. Such medical waste stored for longer than 72 hours during post-collection storage period shall be maintained at a temperature of 45 degrees Fahrenheit or less.

(j) Treatment requirements. Medical waste shall be treated in accordance with the provisions of 25 TAC §1.136 (relating to Approved Methods of Treatment and Disposition). The owner or operator shall provide a written procedure for the operation and testing of any equipment used and for the preparation of any chemicals used in treatment and comply with the following:

  (1) The operator shall demonstrate a minimum four log ten reduction as defined in 25 TAC §1.132 (relating to Definitions) on routine performance testing using appropriate Bacillus species biological indicators (as defined in 25 TAC §1.132).

  (2) The operator shall conduct testing weekly.

  (3) For those processes that the manufacturer has documented compliance with the performance standard prescribed in 25 TAC §1.135 based on specified parameters (for example, pH, temperature, pressure, etc.), and for previously approved treatment processes that a continuous readout and record of operating parameters is available, the operator may substitute routine parameter monitoring for biological monitoring. The operator shall confirm that any chemicals or reagents used as part of the treatment process are at the effective treatment strength. The operator will maintain records of operating parameters and reagent strength for three years.

  (4) The manufacturer of single-use, disposable treatment units shall be responsible for maintaining adequate quality control for each lot of single-use products. The treating facility or entity shall be responsible for following the manufacturer's instructions.

  (5) Operators of medical waste treatment equipment shall use backflow preventers on any potable water connections to prevent contamination of potable water supplies.

  (6) Owners or operators of medical waste incinerators shall comply with the requirements in §111.123 of this title (relating to Medical Waste Incinerators) in lieu of biological or parametric monitoring.

  (7) Alternative treatment technologies may be approved in accordance with requirements found in 25 TAC §1.135 (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities).

(k) Closure plan. The facility closure plan shall be prepared in accordance with the following criteria.

  (1) Facility units shall be dismantled and removed off-site or decontaminated.

  (2) The owner or operator shall remove all waste and material on-site (unprocessed, in process, and processed), transport them to an authorized facility and disinfect all contaminated water handling units and all processing areas.

  (3) Closure of the facility must be completed within 180 days following the last acceptance of processed or unprocessed materials unless otherwise directed or approved in writing by the executive director.

(l) Certification of final closure.

  (1) No later than 90 days prior to the initiation of a final facility closure, the owner or operator shall, through a published notice in the newspaper(s) of largest circulation in the vicinity of the facility, provide public notice for final facility closure. This notice shall provide the name, address, and physical location of the facility; the registration number, as appropriate; and the last date of intended receipt of waste. The owner or operator shall also make available an adequate number of copies of the approved final closure plan for public access and review. The owner or operator shall also provide written notification to the executive director of the intent to close the facility and place this notice of intent in the operating record.

  (2) Upon notification to the executive director as specified in paragraph (1) of this subsection, the owner or operator of a medical waste management facility shall post a minimum of one sign at the main entrance and all other frequently used points of access for the facility notifying all persons who may utilize the facility of the date of closing for the entire facility and the prohibition against further receipt of waste materials after the stated date. Further, suitable barriers shall be installed at all gates or access points to adequately prevent the unauthorized dumping of solid waste at the closed facility.

  (3) Within ten days after completion of final closure activities of a facility, the owner and operator shall submit to the executive director by registered mail:

    (A) a certification, signed by an independent licensed professional engineer, verifying that final facility closure has been completed in accordance with the approved closure plan. The submittal to the executive director shall include all applicable documentation necessary for certification of final facility closure; and

    (B) a request for voluntary revocation of the facility registration.

(m) Cost estimate for closure.

  (1) The cost estimate must:

    (A) equal the costs for closure of the facility, including disposition of the maximum inventories of all processed and unprocessed waste;

    (B) be based on the costs of hiring a third party that is not affiliated with the owner or operator; and


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