Document jBQa886RdnNYnMEwRR2gaZw0p
As explained further in the attached letter submitted to EPA on March 17 on behalf of the Ethylene Oxide Sterilization Association (EOSA), the technology necessary to implement the standards is not available because manufacturers cannot guarantee that existing emissions control equipment will enable sources to meet the new standards; there is not a sufficient supply of the necessary technology; and there are not enough experienced installation professional and technical experts to install and test that equipment within the current compliance timeframes.
As also explained further in EOSA's March 17 letter, it is in the national security interests of the United States to issue the requested exemption because if some facilities choose to cease operations rather than attempt compliance (which is likely), that will disrupt the supply of sterilized medical devices, raise the cost of those devices, and/or force medical suppliers or providers to source sterilized medical devices from abroad.
Please don't hesitate to let me know if any additional information is needed. MedXL appreciates EPA's attention to this important matter and urges EPA to recommend that the President issue the requested exemption as quickly as possible.
Thank you!
MEDXL
Ste*i'Adaniietz, QA/RA Manager, Management Representative
sadamietz(cemedx1pro.com Office: 580-226-7808 ext.4206 Cell: 405-207-4394 3204 Hale Road Ardmore, OK 73401
Sierra Club FOIA 2025-EPA-04883
ED_018388_00005448-00002
SC_EVERSPLIT0005385