Document qm3qYVVNZbxYa56E3Y91z3Dj5

This would be for our ETO sterilizing facility: Long Island Sterilization. Long Island Sterilization has common ownership with our medical device manufacturing company, Robert Busse & Co. dba Busse Hospital Disposables. Busse Hospital Disposables (Busse) is a small woman owned company located in the Hauppauge Industrial Park located in Hauppauge, NY. our facilities are located two blocks from each other. Busse Hospital Disposables is in direct control of Long Island Sterilization (LIS) , we have been sterilizing medical devices for over 26 years. We are currently operating under a permit from the New York DEC. We have applied for an extension for our permit to take us into next year. We are currently in full compliance with NYS DEC regulations but will need to start upgrading our sterilization facility to be incompliance with the NESHAP rules. Busse Hospital Disposables & LIS injection mold, assemble, package and sterilize over 18 million medical products / yr. Busse has been in operation as a manufacturer for over 45 years and in business for over 60 years. We currently have 260 full time employees. Our products are used throughout the entire healthcare spectrum from Hospitals to Ambulatory Centers, Doctors offices and nursing homes We currently have a Federal Supply Schedule contract with VA Health system. Most of the sales of our products are done through our distributors such as Cardinal Health, Medline Industries, Henry Schein, McKesson Medical, Owens & Minor and over 100 local and regional distributors. We also export our medical devices overseas. Along with a full line of single use, procedural kits & trays, surgical drapes and OR suction products under the Busse brand, we also manufacture private branded products for many well-known companies in the US. We also manufacture OEM parts to other medical device manufacturers for use in their sterile procedural kits, trays & surgical packs. We are requesting a period of at least two years to become compliant with the new NESHAP regulations. We are asking this because: 1) We feel the necessary upgrades to our existing equipment along with new construction in our facility will be quite costly for our company. 2) There will also be a required purchase of additional monitoring equipment. This will be a very large capital expense for us and most be done in stages for cash flow as well as staying in successful day to day operation as a business. The technology exists but is not inexpensive. Sierra Club FOIA 2025-EPA-04883 ED_0l 8388_00005604-00002 SC_EVERSPLIT0006413