| (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
(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
(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
(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
(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
(B) be based on the costs of hiring a third party that
is not affiliated with the owner or operator; and
(C) be based on a volume (cubic yard) and/or weight
(pound, ton) measure for collection and disposition costs.
(2) An increase in the closure cost estimate and the
amount of financial assurance provided under subsection (n) of this
section must be made if changes to the facility conditions increase
the maximum cost of closure at any time during the active life of
(3) A reduction in the closure cost estimate and the
amount of financial assurance provided under subsection (n) of this
section may be approved if the cost estimate exceeds the maximum cost
of closure at any time during the operation of the facility. A reduction
in the cost estimate and the financial assurance must be considered
a modification and the owner or operator shall provide a detailed
justification for the reduction of the closure cost estimate and the
amount of financial assurance.
(n) Financial assurance. A copy of the documentation
required to demonstrate financial assurance as specified in Chapter
37, Subchapter R of this title (relating to Financial Assurance for
Municipal Solid Waste Facilities) shall be submitted 60 days prior
to the initial receipt of waste. Continuous financial assurance coverage
for closure must be provided until all requirements of the final closure
plan have been completed and the facility is determined to be closed
in writing by the executive director.
(o) Site operating plan. This plan will provide general
operating procedures for facility management for day-to-day operations
at the facility. At a minimum, the site operating plan must include
a description for how the items in §326.75 of this title (relating
to Site Operating Plan) will be implemented. A facility that has an
environmental management system that meets the minimum standards described
in §90.30 of this title (relating to Minimum Standards for Environmental
Management Systems) and is approved to operate under an environmental
management system in accordance with §90.31 of this title (relating
to Review of Incentive Applications for Environmental Management System),
is not subject to site operating plan requirements while the authorization
to operate under the environmental management system remains in place.
In the event the executive director terminates authorization to operate
under an environmental management system, the facility must comply
with the site operating plan requirements within 90 days.
(p) The approved site operating plan, the final closure
plan, and all other documents and plans required by this chapter shall
become operational requirements and shall be considered a part of
the operating record of the facility. Any deviation from the registration,
the incorporated plans, or any other documents associated with the
registration is a violation of this chapter.