| (a) Exemptions.
(1) Unless an item is specifically exempted, all special
waste from health care-related facilities must be treated as provided
in these sections.
(2) These sections do not apply to:
(A) teeth;
(B) human fetal tissue as defined in the Texas Health
and Safety Code, Chapter 173, and donated in accordance with that
chapter, and human tissue donated for research or teaching purposes,
with the consent of the person authorized to consent as otherwise
provided by law, to an institution of higher learning, medical school,
a teaching hospital affiliated with a medical school, or to a research
institution or individual investigator subject to the jurisdiction
of an institutional review board required by 42 United States Code
289;
(C) placentas designated for sale and obtained from
a licensed hospital or a licensed birthing center;
(D) in vitro tissue cultures that have not been intentionally
exposed to pathogens;
(E) any material included in the definition of special
waste from health care-related facilities which has been sold, donated,
or in any way transferred from one health care-related facility to
a subsequent facility(s) and other entities specified in subparagraph
(B) of this paragraph for research or teaching purposes until it is
discarded;
(F) human tissue that is expelled or removed from the
human body once the person is outside of a healthcare facility;
(G) the remains of an unintended, intrauterine fetal
death required to be released to the parent of an unborn child pursuant
to Texas Health and Safety Code, §241.010;
(H) a placenta removed from a hospital or birthing
center pursuant to Texas Health and Safety Code, Chapter 172; and
(I) embryonic and fetal tissue remains subject to the
Texas Health and Safety Code, Chapter 697.
(b) Minimum parametric standards for waste treatment
technologies previously approved by the department.
(1) Chemical disinfection.
(A) Waste treatment via direct contact with chemical
agents only shall utilize a registered chemical agent or an approved
unregistered chemical agent as follows.
(i) Registered chemical agents.
(I) The chemical agent used shall be registered with
the United States Environmental Protection Agency and the Texas Department
of Agriculture.
(II) The chemical agent shall be used according to
the manufacturer's instructions.
(ii) Unregistered chemical agents.
(I) Those unregistered chemical agents previously approved
are:
(-a-) a freshly prepared solution of household chlorine
bleach diluted 1:10 (volume/volume) with water; or
(-b-) a solution of 70% by volume 2-propanol (isopropyl
alcohol).
(II) The containerized waste items shall be totally
immersed in either solution for a period of time not less than three
minutes.
(B) If a chemical agent has been included by a manufacturer
of a commercially-available waste treatment technology as the principle
step in the treatment process, then:
(i) the chemical agent (or its precursor(s)) or the
microbial inactivating process must be registered with the United
States Environmental Protection Agency for the purpose of waste treatment;
or
(ii) the manufacturer must provide evidence that the
technology utilizing said chemical agent (or its precursor(s)) or
the microbial inactivating process has been approved for use in another
state; or
(iii) the manufacturer must obtain approval for the
process 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).
(C) Waste immersed in a liquid chemical agent must
be thoroughly drained before disposal.
(2) Chlorine disinfection/maceration.
(A) The waste must be shredded prior to or during treatment
and made unrecognizable as to source.
(B) The chlorine solution must have a free available
chlorine concentration of at least 1,100 parts per million (ppm) when
applied to the waste.
(C) The chlorine solution must be drained from the
waste prior to disposal.
(3) Moist heat disinfection. Moist heat disinfection
shall utilize either of the following processes.
(A) When subjecting internally shredded waste to moist
heat assisted by microwave radiation, the temperature of the waste
must reach at least 95 degrees Celsius under atmospheric pressure
for at least 30 minutes.
(B) When subjecting unshredded waste in sealed containers
to moist heat assisted by low-frequency radiowaves, the temperature
of the waste must reach at least 90 degrees Celsius under atmospheric
pressure for at least two hours, followed by shredding of the waste
to the extent that the identity of the waste is unrecognizable.
(4) Steam disinfection. Steam disinfection shall meet
all of the following requirements.
(A) To allow for sufficient steam access to or penetration
of the waste, the waste shall be:
(i) packaged according to the recommendations provided
by the manufacturer; and
(ii) loaded into the chamber so as to not exceed the
capacity limits as set by the manufacturer.
(B) When subjecting waste to steam under pressure,
the temperature in the chamber of the autoclave must reach at least
121 degrees Celsius and there must be at least 15 pounds per square
inch gauge pressure for at least 30 minutes.
(C) The autoclave must be operated according to the
manufacturer's instructions.
(5) Thermal inactivation. Thermal inactivation shall
meet all of the following requirements.
(A) To allow for sufficient dry heat access to or penetration
of the waste, the waste shall be:
(i) packaged according to the recommendations provided
by the manufacturer; and
(ii) loaded into the chamber so as to not exceed the
capacity limits as set by the manufacturer.
(B) Waste shall be subjected to dry heat of at least
160 degrees Celsius under atmospheric pressure for at least two hours.
(C) Waste shall be subjected to dry heat according
to the manufacturer's instructions.
|
| Source Note: The provisions of this §1.133 adopted to be effective December 21, 1994, 19 TexReg 9599; amended to be effective December 18, 2016, 41 TexReg 9709; amended to be effective May 24, 2018, 43 TexReg 3242 |
