Public Notice of Intent to Issue Air Permit

Public Notice of Intent to Issue Air Permit Public Notice of Intent to Issue Air Permit Florida Department of Environmental Protection Division of Air Resource Management, Permit Review Section Draft Air Permit No. 0210122-004-AC Arthrex, Inc., Arthrex Manufacturing Inc. Finishing (AMIF) Collier County, Florida Applicant: The applicant for this project is Arthrex, Inc. The applicant's authorized representative and mailing address is: Scott Beauchesne, Process Safety Engineer, Arthrex, Inc., AMIF, 6875 Arthrex Commerce Drive, Ave Maria, FL 34142. Facility Location: Arthrex, Inc. operates the existing Arthrex Manufacturing Inc. Finishing (AMIF), which is in Collier County at 6875 Arthrex Commerce Drive in Ave Maria, Florida. Project: The AMIF consists of 2 operations on facility grounds: a manufacturing facility for medical and surgical devices and a finishing facility for sterilizing the devices. The manufacturing facility houses various implant and surgical device manufacturing operations. The operating floor contains material milling, three-dimensional (3D) printing, molding, and assembly operations. Operations that result in dust are enclosed in booths that exhaust into the building. Suture manufacturing is completed at the manufacturing building, where suture braids are coated with a xylene solvent. The facility also includes 3 diesel-fired emergency engines that power generators to supply power to the building in response to power outages and 1 diesel-fired emergency engine driven fire pump. The finishing facility is a separate, detached facility located on the north side of the Arthrex property. The finishing facility consists of four identical sterilization lines with the following stages: preconditioning, sterilization, and aeration. During sterilization, the products are exposed to EtO to eliminate potential biological contaminants. During aeration, EtO is removed until the concentrations in the chamber drop below set levels, and the products are transferred to a storage area for shipping. The finishing facility is supported by 2 diesel-emergency generators that supply power to the building in response to power outages. This facility previously operated under an Air General Permit (AGP) issued under the authority of Rule 62-210.310, F.A.C. and continues to operate under an AGP until the permit expiration date of April 7, 2028. On June 1, 2023, the Department revised Rule 62-210.310, F.A.C. such that facilities comprising ethylene oxide sterilizers are no longer authorized to operate under an AGP. Additionally, 40 CFR 63, Subpart O – Ethylene Oxide Emissions Standards for Sterilization Facilities has been amended. Subpart O requires additional emissions and operating limitations on various affected sources throughout the sterilization process by either 2028 or 2029. Prior to these compliance dates, the facility will be required to comply with applicable requirements of the previous version of Subpart O. This project authorizes the construction of control and monitoring technology needed to comply with the current version of Subpart O, including installation of a dry bed scrubber for control of Group 1 and Group 2 room air emissions, permanent total enclosure of the sterilization and aeration process, and an EtO continuous emissions monitoring system (CEMS). Additionally, the facility will be subject to an enforceable EtO usage limit of 40 tons per consecutive 12-month period. Permitting Authority: Applications for air construction permits are subject to review in accordance with the provisions of Chapter 403, Florida Statutes (F.S.) and Chapters 62-4, 62-210 and 62-212 of the Florida Administrative Code (F.A.C.). The proposed project is not exempt from air permitting requirements and an air permit is required to perform the proposed work. The Permitting Authority responsible for making a permit determination for this project is the Permit Review Section in the Department of Environmental Protection's Division of Air Resource Management. The Permitting Authority's physical address is: 2600 Blair Stone Road, Tallahassee, Florida. The Permitting Authority's mailing address is: 2600 Blair Stone Road, MS #5505, Tallahassee, Florida 32399-2400. The Permitting Authority's phone number is 850-717-9000. Project File: A complete project file is available for public inspection during the normal business hours of 8:00 a.m. to 5:00 p.m., Monday through Friday (except legal holidays), at the address indicated above for the Permitting Authority. The complete project file includes the Draft Permit, the Technical Evaluation and Preliminary Determination, the application and information submitted by the applicant (exclusive of confidential records under Section 403.111, F.S.). Interested persons may contact the Permitting Authority's project engineer for additional information at the address and phone number listed above. In addition, electronic copies of these documents are available on the following web site by entering the draft permit number: https://fldep.dep.state.fl.us/air/emission/apds/default.asp. Notice of Intent to Issue Air Permit: The Permitting Authority gives notice of its intent to issue an air construction permit to the applicant for the project described above. The applicant has provided reasonable assurance that operation of proposed equipment will not adversely impact air quality and that the project will comply with all applicable provisions of Chapters 62-4, 62-204, 62-210, 62-212, 62-296 and 62-297, F.A.C. The Permitting Authority will issue a Final Permit in accordance with the conditions of the proposed Draft Permit unless a timely petition for an administrative hearing is filed under Sections 120.569 and 120.57, F.S. or unless public comment received in accordance with this notice results in a different decision or a significant change of terms or conditions. Comments: The Permitting Authority will accept written comments concerning the proposed Draft Permit for a period of 14 days from the date of publication of the Public Notice. Written comments must be received by the Permitting Authority by close of business (5:00 p.m.) on or before the end of this 14-day period to the above address and electronically to David Read at David.Read@FloridaDEP.gov. If written comments received result in a significant change to the Draft Permit, the Permitting Authority shall revise the Draft Permit and require, if applicable, another Public Notice. All comments filed will be made available for public inspection. Petitions: A person whose substantial interests are affected by the proposed permitting decision may petition for an administrative hearing in accordance with Sections 120.569 and 120.57, F.S. Petitions filed by any persons other than those entitled to written notice under Section 120.60(3), F.S., must be filed within 14 days of publication of the Public Notice or receipt of a written notice, whichever occurs first. Under Section 120.60(3), F.S., however, any person who asked the Permitting Authority for notice of agency action may file a petition within 14 days of receipt of that notice, regardless of the date of publication. A petitioner shall mail a copy of the petition to the applicant at the address indicated above, at the time of filing. A petition for administrative hearing must contain the information set forth below and must be filed (received) with the Agency Clerk in the Office of General Counsel, 3900 Commonwealth Boulevard, MS 35, Tallahassee, Florida 32399-3000, Agency_Clerk@dep.state.fl.us, before the deadline. The failure of any person to file a petition within the appropriate time period shall constitute a waiver of that person's right to request an administrative determination (hearing) under Sections 120.569 and 120.57, F.S., or to intervene in this proceeding and participate as a party to it. Any subsequent intervention (in a proceeding initiated by another party) will be only at the approval of the presiding officer upon the filing of a motion in compliance with Rule 28-106.205, F.A.C. A petition that disputes the material facts on which the Permitting Authority's action is based must contain the following information: (a) The name and address of each agency affected and each agency's file or identification number, if known; (b) The name, address, any email address, telephone number and any facsimile number of the petitioner; the name, address any email address, telephone number, and any facsimile number of the petitioner's representative, if any, which shall be the address for service purposes during the course of the proceeding; and an explanation of how the petitioner's substantial interests will be affected by the agency determination; (c) A statement of when and how each petitioner received notice of the agency action or proposed decision; (d) A statement of all disputed issues of material fact. If there are none, the petition must so state; (e) A concise statement of the ultimate facts alleged, including the specific facts the petitioner contends warrant reversal or modification of the agency's proposed action; (f) A statement of the specific rules or statutes the petitioner contends require reversal or modification of the agency's proposed action including an explanation of how the alleged facts relate to the specific rules or statutes; and, (g) A statement of the relief sought by the petitioner, stating precisely the action the petitioner wishes the agency to take with respect to the agency's proposed action. A petition that does not dispute the material facts upon which the Permitting Authority's action is based shall state that no such facts are in dispute and otherwise shall contain the same information as set forth above, as required by Rule 28-106.301, F.A.C. Because the administrative hearing process is designed to formulate final agency action, the filing of a petition means that the Permitting Authority's final action may be different from the position taken by it in this Public Notice of Intent to Issue Air Permit. Persons whose substantial interests will be affected by any such final decision of the Permitting Authority on the application have the right to petition to become a party to the proceeding, in accordance with the requirements set forth above. Extension of Time: Under Rule 62-110.106(4), F.A.C., a person whose substantial interests are affected by the Department's action may also request an extension of time to file a petition for an administrative hearing. The Department may, for good cause shown, grant the request for an extension of time. Requests for extension of time must be filed with the Office of General Counsel of the Department at 3900 Commonwealth Boulevard, Mail Station 35, Tallahassee, Florida 32399-3000, or via electronic correspondence at Agency_Clerk@dep.state.fl.us, before the deadline for filing a petition for an administrative hearing. A timely request for extension of time shall toll the running of the time period for filing a petition until the request is acted upon. Mediation: Mediation is not available in this proceeding. November 24 2025 LSAR0410939