Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 1 - MISCELLANEOUS PROVISIONS
Subchapter K - DEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES
Section 1.135 - Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities
Universal Citation: 25 TX Admin Code ยง 1.135
Current through Reg. 49, No. 38; September 20, 2024
All manufacturers of commercially-available alternate technologies, equipment, or processes designed or intended for the treatment of special waste from health care-related facilities, except those meeting the standards of § 1.133(b) of this title (relating to Scope, Covering Exemptions and Minimum Parametric Standards for Waste Treatment Technologies Previously Approved by the Texas Department of State Health Services), shall apply to the department on forms prescribed by the department for approval of said technologies, equipment, or processes to ensure that established performance standards are met.
(1) Levels of microbial inactivation.
(A) All laboratory evidence submitted to the
department for review shall be provided by a laboratory that meets the
standards of either the NSF International, the American Association for
Laboratory Accreditation, or other accrediting agencies or organizations as
approved by the department.
(B) All
manufacturers of commercially-available alternate technologies, equipment, or
processes designed and intended for the treatment of special waste from health
care-related facilities shall provide specific laboratory evidence that
demonstrates:
(i) inactivation of
representative samples of vegetative bacteria, mycobacteria,
lipophilic/hydrophilic viruses, fungi, and parasites at a level of 6
log10 reduction or greater, as determined by the
department; and
(ii) inactivation
of Bacillus stearothermophilus endospores or Bacillus subtilis endospores at a
level of 4 log10 reduction or greater, as determined by
the department.
(C) One
or more representative surrogate microorganisms from each microbial group shall
be used in treatment efficacy evaluation. The department shall determine the
appropriate microorganisms to serve as representative surrogate
microorganisms.
(D) The department
shall prescribe those categories (types) and percent composition of special
waste from health care-related facilities that present the most challenge to
said treatment effectiveness under normal operating conditions of the equipment
or process.
(E) Protocols developed
for efficacy testing shall incorporate, as applicable, recognized, standard
procedures. The protocols shall be congruent with the treatment method under
review. The department shall determine the specific pieces of information to be
provided by the manufacturer to assure a thorough evaluation of the alternate
treatment technology.
(2) Documentation requirements.
(A) The manufacturer of the alternate
treatment technology, equipment, or process shall provide to the department the
following information:
(i) a detailed
description of the treatment equipment, equipment specifications, operating
instructions, and parameters of normal operation, and information detailing the
intended use and typical site for which the equipment is designed;
(ii) complete documentation that the
alternate treatment technology, equipment, or process meets microbial
inactivation criteria for all required representative microorganisms for all
department-specified challenge waste load compositions, including a description
of the test methods used, and, upon request, the original data from test
procedures conducted by the manufacturer;
(iii) documentation on available parametric
controls, and, where technically feasible, evidence that demonstrates the
efficacy relationship between biological indicator data and data derived from
real-time parametric monitoring equipment;
(iv) details relating to waste residues
including their potential hazards/toxicities and their specific mode of
disposal or recycling;
(v)
documentation providing occupational health assurance, and the means of
providing required training in equipment operations;
(vi) evidence of United States Environmental
Protection Agency registration and Texas Department of Agriculture registration
for those treatment processes that employ a chemical agent to inactivate
microorganisms, or evidence of approval of the treatment process by a state
other than Texas;
(vii)
documentation that user verification testing protocols are workable and valid;
and
(viii) documentation of
approval of the alternate treatment process or technology in other state(s)
utilizing performance standard review, if applicable.
(B) Documentation must be submitted to the
department on forms provided by the department.
(3) Alternate treatment technology approval conditions.
(A) The alternate treatment
technology approval is contingent upon the following conditions:
(i) Alternate treatment technology approval
is granted only for the conditions specified in the manufacturer's
instructions, equipment specifications, and operating procedures and
conditions, including but not limited to:
(I)
treatment time(s);
(II)
temperature(s);
(III)
pressures;
(IV) chemical
concentration(s);
(V) irradiation
dose(s);
(VI) feed rate(s);
and
(VII) waste load
composition(s).
(ii) Any
significant revision on the part of the manufacturer to either the operating
conditions of the equipment's existing process or technology, or the
fundamental principles of the process itself, i.e., the equipment now utilizes
a different technology in part or altogether, will require re-application for
approval to the department.
(B) Prior approval granted by a state other
than Texas that utilizes a performance standards approach to review alternate
treatment technologies shall be considered as a basis for approval by the
department if the department is provided with a valid and current approval,
license, or permit issued by such state and substantial evidence to indicate
that the performance standards upon which the approval, license, or permit was
issued are equal to or more stringent than the performance standards included
in this section.
(C) Facilities are
not obligated to petition the department for approval for previously approved
waste treatment technology they have currently on site, but the following items
will apply should current equipment be replaced, regardless of reason:
(i) if the new equipment reflects a
previously approved technology and is operated in accordance with §
1.133(b)
of this title, then purchase and installation can proceed without further
action on the part of the department or the purchaser; or
(ii) if the new equipment represents an
alternate treatment technology subject to prior approval by the department,
based on performance standards as outlined in this section, then it is the
purchaser's responsibility to ensure that the manufacturer has obtained such
approval prior to purchase.
(4) Fees and annual listing.
(A) Initial application fee.
(i) The department shall charge an initial
application fee for the evaluation of an alternate treatment technology
pursuant to this section in the amount of $4,000.
(ii) The initial application fee must be paid
in full before the department undertakes its evaluation of the manufacturer's
alternate treatment technology.
(B) Annual listing.
(i) Alternate treatment technologies must be
listed at the time of the manufacturer's first sale of the product in Texas and
prior to the product's purchase by a health care-related facility or any other
person.
(ii) Failure by the
manufacturer to maintain the listing after purchase does not preclude use of
the alternate treatment technology, its transfer or re-sale, so long as
compliance with §
1.136(c)
of this title (relating to Approved Methods of Treatment and Disposition) is
achieved.
(iii) The department
shall maintain a list of those approved alternate treatment technologies,
including manufacturer, product name, model number, or other appropriate
identifying information. The list shall be made available and distributed upon
request by contacting the department.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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