Overview
The Texas Department of State Health Services recently issued a final rule implementing updated methods for the disposal of special waste from health care facilities, which includes fetal tissue. As such, the new rule would require health care facilities to dispose of fetal tissue by cremation and/or burial. Furthermore, it would no longer allow for fetal tissue to be disposed in a sanitary landfill and the burden for determining a proper method of disposal for this tissue is placed upon the health care facility.
The rule was due to take effect on December 18, 2016, but was temporarily halted by the U.S. District Court for the Western District of Texas. Hearings on the rule are to be held on January 3 and 4 of 2017 and this new rule would not go into effect until January 6, 2017, at the earliest, if at all. It remains to be seen whether the district court which stayed the rule will strike it down entirely, partially, or will allow it to go into effect early next year.
What Would Be Required?
The rule would require that all “special waste from health care-related facilities” be disposed of according to this new rule, unless it meets one of the exemptions. Depending on the specific type of waste, proper disposal methods include cremation, interment, steam disinfection, incineration, chemical disinfection, or a number of other treatments, followed by deposition in a sanitary landfill. However, under the new rule, “fetal tissue” (defined to exclude the umbilical cord, placenta, gestational sac, blood and body fluids) could not be disposed of in a sanitary landfill.
What Are the Exemptions?
The rule encompasses several exemptions, such as instances involving human and fetal tissue resulting from any miscarriage or abortion that occurs outside of a health care facility (e.g., at home), human tissue (including “fetal tissue) donated for research or teaching purposes, or fetal remains released to the parents.
Effective Date
Health care-related facilities should remain aware of the outcome of the hearings on January 3 and 4 to be heard in the Western District of Texas and, in the meantime, familiarize themselves with the Final Rule to ensure their ability to comply if and when the Final Rule is implemented.
