North Carolina Administrative Code
Title 15A - Environmental Quality
Chapter 02 - ENVIRONMENTAL MANAGEMENT
Subchapter D - AIR POLLUTION CONTROL REQUIREMENTS
Section .0500 - EMISSION CONTROL STANDARDS
Section 02D .0538 - CONTROL OF ETHYLENE OXIDE EMISSIONS
Current through Register Vol. 39, No. 6, September 16, 2024
(a) For purposes of this Rule, "medical devices" means instruments, apparatus, implements, machines, implants, in vitro reagents, or other similar or related articles including their components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or intended to affect the structure or any function of the body of man or other animals.
(b) This Rule applies to emissions at facilities for which construction began after August 31, 1992 of ethylene oxide resulting from use as a sterilant in:
(c) This Rule does not apply to hospital or medical facilities.
(d) Facilities subject to this Rule shall comply with the following standards:
(e) Before installation of the controls required by Paragraph (d) of this Rule, and annually thereafter, a written description of waste reduction, elimination, or recycling plan shall be submitted to the Director to determine if ethylene oxide use can be reduced or eliminated through alternative sterilization methods or process modifications.
(f) The owner or operator of the facility shall conduct a performance test to verify initial efficiency of the control devices. The owner or operator shall maintain temperature records to demonstrate proper operation of the degassing room. For the purposes of this Paragraph, "proper operation" means in accordance with the manufacturer's specifications. Such records shall be retained for a period of at least two calendar years and shall be made available for inspection by Division personnel.
(g) If the owner or operator of a facility subject to the Rule demonstrates, using the procedures in 15A NCAC 02D .1106, that the emissions of ethylene oxide from all sources at the facility do not cause the acceptable ambient level of ethylene oxide in 15A NCAC 02D .1104 to be exceeded, then the requirements of Paragraphs (d) through (e) of this Rule shall not apply. This demonstration shall be at the option of the owner or operator of the facility. If this option is chosen, the Director shall write the facility's permit to satisfy the requirements of 15A NCAC 02D .1104(a).
Authority
G.S.
143-215.3(a)(1);
143-215.107(a)(4),(5);
143-215.108(c);
Eff. September 1, 1992;
Amended Eff. June 1, 2004; August 1,
2002;
Readopted Eff. November 1, 2020;
Amended Eff.
October 1, 2022.