(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
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