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 log
10 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.
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