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 [Texas
Department of Health (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)(No change.)
(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 [
log[sub]10[/sub]] 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 [log[sub]10[/sub]] reduction
or greater, as determined by the department.
(C) - (E)(No change.)
(2)Documentation requirements.
(A)(No change.)
(B)Documentation must be submitted to the department
[Texas Department of Health, Bureau of Environmental Health]
on [those] forms provided by the department.
(3) - (4)(No change.)
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to adopt.
Filed with the Office
of the Secretary of State on September 19, 2016
TRD-201604843 Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: October 30, 2016
For further information, please call: (512) 776-6972
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