| (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
Cont'd... |
