|(a) A large quantity generator (LQG) that treats all
or part of the medical waste generated on-site shall provide written
notification to the executive director of the operation of an approved
treatment process unit used only for the treatment of medical waste
generated on-site in accordance with the provisions of 25 TAC §1.136
(relating to Approved Methods of Treatment and Disposition). 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). This one-time notification
(1) the contact information for the generator;
(2) if applicable, the name, address, telephone number,
and the Texas Commission on Environmental Quality authorization number
of the mobile treatment operator providing treatment; and
(3) the method/conditions of treatment.
(b) A LQG shall maintain on-site a written record that
contains the information listed in subsection (a) of this section
and the following:
(1) the name (printed) and initials of the person(s)
(2) the dates of treatment;
(3) the amounts of waste treated; and
(4) written procedure for the operation and testing
of any equipment used and written procedure for the preparation of
any chemicals used in the treatment.
(A) 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). The operator
shall conduct testing at the following intervals:
(i) for generators of more than 50 pounds but less
than or equal to 100 pounds per month, testing shall be conducted
at least once per month;
(ii) for generators of more than 100 pounds but less
than or equal to 200 pounds per month, testing shall be conducted
at least every two weeks; and
(iii) for generators of more than 200 pounds per month
testing shall be conducted at least weekly.
(B) 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),
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, if applicable, for three years.
(C) 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.
(D) 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
(c) Disposal of treated medical waste. Medical wastes
that have been treated in accordance with the provisions of 25 TAC §1.136
may be managed as routine municipal solid waste unless otherwise specified
in paragraphs (1) - (5) of this subsection.
(1) Incinerator ash shall be disposed of in a permitted
landfill in accordance with Chapter 330 of this title (relating to
Municipal Solid Waste).
(2) Treated microbiological waste, blood, blood products,
body fluids, laboratory specimens of blood and tissue, and animal
bedding may be disposed of in a permitted landfill. Any markings that
identify the waste as a medical waste shall be covered with a label
that identifies the waste as treated medical waste. The identification
of the waste as treated may be accomplished by the use of color-coded,
disposable containers for the treated waste or by a label that states
the contents of the disposable container have been treated in accordance
with the provisions of 25 TAC §1.136.
(3) Treated carcasses and body parts of animals designated
as a medical waste may, after treatment, be disposed of in a permitted
landfill in accordance with Chapter 330 of this title. The collection
and transportation of these wastes shall conform to the applicable
local ordinance or rule, if such ordinance or rule is more stringent
than this subsection.
(4) Treated recognizable human body parts, tissues,
fetuses, organs, and the products of human abortions, spontaneous
or induced, shall not be disposed of in a municipal solid waste landfill.
These items shall be disposed of in accordance with the provisions
of 25 TAC §1.136(a)(4).
(5) Sharps treated and containerized with one of the
approved methods as described under 25 TAC §1.136(a)(5) shall
be disposed of in a permitted landfill in accordance with Chapter
330 of this title. Unused sharps shall be disposed of as treated sharps.