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The following words and terms, when used in this subchapter,
shall have the following meanings unless the context clearly indicates
otherwise.
(1)Anatomical remains--The remains of a human body
donated for the purposes of teaching or research to a medical school,
a teaching hospital, or a medical research facility, after the completion
of the activities for which the body was donated.
(2)Animal waste--Animal waste includes:
(A)carcasses of animals intentionally exposed to pathogens;
(B)body parts of animals intentionally exposed to
pathogens;
(C)whole bulk blood and blood products, serum, plasma,
and other blood components from animals intentionally exposed to pathogens;
and
(D)bedding of animals intentionally exposed to pathogens.
(3)Approved alternate treatment process--A process
for waste treatment which has been approved by the department in accordance
with §1.135 of this title (relating to Performance Standards
for Commercially-Available Alternate Treatment Technologies for Special
Waste from Health Care-Related Facilities).
(4)Biological indicators--Commercially-available microorganisms
(e.g., United States Food and Drug Administration-approved strips
or vials of Bacillus species endospores) which can be used to verify
the performance of waste treatment equipment and/or processes.
(5)Blood and blood products--All waste bulk human
blood, serum, plasma, and other blood components.
(6)Body fluids--Those free-flowing body substances
other than blood, plasma, or serum identified under universal precautions
as recommended by the United States Centers for Disease Control and
Prevention, and includes, but are not limited to:
(A)semen;
(B)vaginal secretions;
(C)any body fluid containing visible blood;
(D)saliva in dental settings;
(E)amniotic fluid;
(F)cerebrospinal fluid;
(G)peritoneal fluid;
(H)pleural fluid;
(I)pericardial fluid; and
(J)synovial fluid.
(7)Bulk--A containerized, aggregate volume of 100
milliliters (mL) or more.
(8)Bulk human blood, bulk human blood products, and
bulk human body fluids--All free-flowing waste: human blood; serum;
plasma; other blood components; and body fluids; including disposable
items saturated with blood or body fluids.
(9)Burial--The act of depositing a pathological waste
in a grave, a crypt, vault, or tomb, or at sea.
(10)Burial park--A tract of land that is used or intended
to be used for the interment of pathological waste in graves.
(11)Cemetery--A tract of land that is used or intended
to be used for the permanent interment of pathological waste, and
includes:
(A)a burial park for earth interments;
(B)a mausoleum for crypt or vault interments;
(C)a columbarium for cinerary interments; or
(D)a combination of one or more thereof.
(12)Challenge waste load--A surrogate waste load assembled
for use during waste treatment protocols to evaluate the efficacy
of microbial inactivation processes. The composition of the challenge
waste load will vary depending on the technology being evaluated.
(13)Chemical disinfection--The use of a chemical agent
to reduce significantly the numbers of active microorganisms, but
not necessarily their endospores, from the surfaces of inanimate objects.
(14)Chlorine disinfection/maceration--The process
of shredding waste in the presence of a chlorine solution under negative
pressure.
(15)Columbarium--A structure or room or other space
in a building or structure of most durable and lasting fireproof construction;
or a plot of earth, containing niches, used, or intended to be used,
to contain cremated pathological waste.
(16)Contagious--Capable of transmission from human
or animal to human.
(17)Contaminated--The presence or the reasonably anticipated
presence of blood or those body fluids as defined elsewhere in this
section.
(18)Cremation--The irreversible process of reducing
tissue or remains to ashes or bone fragments through extreme heat
and evaporation. Under this subchapter, this term includes the process
of incineration.
(19)Crematory--A building or structure containing
one or more furnaces used, or intended to be used, for the reduction
(by burning) of pathological waste to cremated remains.
(20)Crypt or vault--The chamber in a mausoleum of
sufficient size to inter the uncremated pathological waste.
(21)Department--The Texas Department of State Health
Services.
(22)Deposition in a sanitary landfill--Deposition
in a sanitary landfill in accordance with 30 TAC Chapter 330.
(23)Discharge to sanitary sewer system--A discharge
or flushing of waste into a sanitary sewer system which is done in
accordance with provisions of local sewage discharge ordinances.
(24)Disinfection--A somewhat less lethal process compared
to sterilization which destroys or inactivates viruses, fungi, and
bacteria (but not necessarily their endospores) on inanimate surfaces.
(25)Encapsulation--The treatment of waste using materials
which, when fully reacted, will encase such waste in a solid protective
matrix.
(26)Entombment--The permanent interment of pathological
waste in a crypt or vault.
(27)Executive Commissioner--In this title, Executive
Commissioner means the Executive Commissioner of the Health and Human
Services Commission.
(28)Fetal Tissue--A fetus, body parts, organs or other
tissue from a pregnancy. This term does not include the umbilical
cord, placenta, gestational sac, blood or body fluids.
(29)Grave--A space of ground in a burial park that
is used, or intended to be used for the permanent interment in the
ground of pathological waste.
(30)Grinding--That physical process which pulverizes
materials, thereby rendering them as unrecognizable, and for sharps,
reduces the potential for the material to cause injuries such as puncture
wounds.
(31)Immersed--A process in which waste is submerged
fully into a liquid chemical agent in a container, or that a sufficient
volume of liquid chemical agent is poured over a containerized waste,
such that the liquid completely surrounds and covers the waste item(s)
in the container.
(32)Incineration--That process of burning SWFHCRF
in an incinerator as defined in 30 TAC Chapter 101 under conditions
in conformance with standards prescribed in 30 TAC Chapter 111 by
the Texas Commission on Environmental Quality.
(33)Interment--The disposition of pathological waste
using the process of cremation, entombment, burial, or placement in
a niche or by using the process of cremation followed by placement
of the ashes in a niche, grave, or scattering of ashes as authorized
by law, unless prohibited by this subchapter.
(34)Log10 --Logarithm
to the base ten.
(35)Log10 reduction--A
mathematically defined unit used in reference to level or degree of
microbial inactivation. A 4 log10 reduction
represents a 99.99% reduction in the numbers of active microorganisms,
while a 6 log10 reduction represents
a 99.9999% reduction in the numbers of active microorganisms.
(36)Mausoleum--A structure or building of most durable
and lasting fireproof construction used, or intended to be used, for
the entombment pathological waste.
(37)Microbial inactivation--Inactivation of vegetative
bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria
at a 6 log10 reduction or greater; and
inactivation of Bacillus subtilis endospores or Bacillus stearothermophilus
endospores at a 4 log10 reduction or
greater.
(38)Microbiological waste--Microbiological waste includes:
(A)discarded cultures and stocks of infectious agents
and associated biologicals;
(B)discarded cultures of specimens from medical, pathological,
pharmaceutical, research, clinical, commercial, and industrial laboratories;
(C)discarded live and attenuated vaccines, but excluding
the empty containers thereof;
(D)discarded, used disposable culture dishes; and
(E)discarded, used disposable devices used to transfer,
inoculate or mix cultures.
(39)Moist heat disinfection--The subjection of:
(A)internally shredded waste to moist heat, assisted
by microwave radiation under those conditions which effect disinfection;
or
(B)unshredded waste in sealed containers to moist
heat, assisted by low-frequency radiowaves under those conditions
which effect disinfection, followed by shredding of the waste to the
extent that the identity of the waste is unrecognizable.
(40)Niche--A recess or space in a columbarium used,
or intended to be used, for the permanent interment of the cremated
remains of pathological waste.
(41)Parametric controls--Measurable standards of equipment
operation appropriate to the treatment equipment including, but not
limited to pressure, cycle time, temperature, irradiation dosage,
pH, chemical concentrations, or feed rates.
(42)Pathological waste--Pathological waste includes
but is not limited to:
(A)human materials removed during surgery, labor and
delivery, autopsy, embalming, or biopsy, including:
(i)body parts;
(ii)tissues or fetuses;
(iii)organs; and
(iv)bulk blood and body fluids;
(B)products of spontaneous or induced human abortions,
regardless of the period of gestation, except as provided by §1.133
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) including:
(i)body parts;
(ii)tissues or fetuses;
(iii)organs; and
(iv)bulk blood and body fluids;
(C)laboratory specimens of blood and tissue after
completion of laboratory examination; and
(D)anatomical remains.
(43)Saturated--Thoroughly wet such that liquid or
fluid flows freely from an item or surface without compression.
(44)Sharps--Sharps include, but are not limited to
the following materials:
(A)when contaminated:
(i)hypodermic needles;
(ii)hypodermic syringes with attached needles;
(iii)scalpel blades;
(iv)razor blades, disposable razors, and disposable
scissors used in surgery, labor and delivery, or other medical procedures;
(v)intravenous stylets and rigid introducers (e.g.,
J wires);
(vi)glass pasteur pipettes, glass pipettes, specimen
tubes, blood culture bottles, and microscope slides;
(vii)broken glass from laboratories; and
(viii)tattoo needles, acupuncture needles, and electrolysis
needles;
(B)regardless of contamination:
(i)hypodermic needles; and
(ii)hypodermic syringes with attached needles.
(45)Shredding--That physical process which cuts, slices,
or tears materials into small pieces.
(46)Special waste from health care-related facilities--A
solid waste which if improperly treated or handled may serve to transmit
an infectious disease(s) and which is comprised of the following:
(A)animal waste;
(B)bulk blood, bulk human blood products, and bulk
human body fluids;
(C)microbiological waste;
(D)pathological waste; and
(E)sharps.
(47)Steam disinfection--The act of subjecting waste
to steam under pressure under those conditions which effect disinfection.
This was previously called steam sterilization.
(48)Thermal inactivation--The act of subjecting waste
to dry heat under those conditions which effect disinfection.
(49)Unrecognizable--The original appearance of the
waste item has been altered such that neither the waste nor its source
can be identified.
The agency certifies that legal counsel has
reviewed the adoption and found it to be a valid exercise of the agency's
legal authority.
Filed with the Office
of the Secretary of State on November 28, 2016
TRD-201606073 Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: December 18, 2016
Proposal publication date: September 30, 2016
For further information, please call: (512) 776-6933
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