Document XOmQeYqVnE5Na3Gjdj2pb24xy

Candace Childers Vice President, Manufacturing Plant Manager 245 Kyle Lane Huntington, WV 25702 Phone: -4-1(304) 733-8636 vvvvvv.alcon.com March 31, 2025 Via Electronic Mail L ". The Honorable Lee Zeldin Administrator L.S. Environmental Protection Agency Mail Code: 1101A 1200 Pennsylvania Avenue, 1N. W. Washington, DC 20460 Re: Presidential Exemption: National Emission Standardsfor Hazardous Air Pollutants: Ethylene Oxide Emissions Standardsfor Sterilization Facilities Residual Risk and Technology Review, 89 Fed. Reg. 24,090 (Apr. 5, 2024): ALCON Research Ltd., ALCON Advance Optic Device Center, North Facility, 2 Vision Lane, Lesage, Cabell County, West Virginia 25537 Dear Administrator Zeldin: AI.CON Research Ltd.'s AI.CON Advance Optic Device Center, North Facility located at 2 Vision Lane, Lesage in Cabell County, West Virginia (AODC) respectfully requests a two-year Presidential Exemption from the National Emission ,Standardsfor Hazardous Air Pollutants: Ethylene Oxide Emissions Standardsfir Sterilization Facilities Residual Risk and Technology Review regulation, published at 89 Fed. Reg. 24,090 (Apr. 5, 2024) (Et0 NFSHAP Rule). The Emissions Standards or Limitations Subject to the Request: Nan-omit Emission .Standards for Hazardous Air Pollutants: Ethylene Oxide EmiSsions ,S'tandards' for,S.terilization Facilities Residual Risk and technology Review, published at 89 Fed. Reg. 24,090 (Apr. 5, 2024), and 40 C.F.R. Part 63, Subpart O. The limitations that are the subject of this exemption request include the emission standards and emission capture requirements applicable to sterilization chamber vents, aeration room vents, Group 1 Room emissions, and Group 2 Room emissions, the Permanent Total Enclosure (PTF.) requirements of EPA Method 204 of Appendix M, 40 C.F.R. Part 51, and the requirement to install and operate Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00001 SC_EVERSPLIT0012432 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 2 Continuous Emission Monitors (CEMs) in accordance with the requirements of Performance Specification 19 in Appendix B and Procedure 7 in Appendix F to 40 C.F.R. Part 60, all as applied at AODC. Exemption Period Request: AI.CON Research, Ltd., is requesting a two-year Presidential Exemption and extension of the applicable compliance deadlines of the National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standardsl0r Sterilization Facilities Residual Risk and Technology Review regulation, published at 89 Fed. Reg. 24,090 (Apr. 5, 2024), as applied at AODC. Backzround Founded more than 75 years ago in Fort Worth, Texas, AI.CON is the largest eye care company in the world. It is the global leader in eye care, dedicated to helping people See Brilliantly. Today, more than one billion people live with some form of uncorrected visual impairment. The impact of these treatable problems is significant. We see a world where treatable, preventable eye health conditions receive the attention they need, regardless of an individual's geography, gender, age or socioeconomic status. Our Social Impact and Sustainability strategy is focused on three pillars Brilliant Lives, Brilliant Innovation and Brilliant Planet. The pillars include social impact and environmental goals that hold us accountable and measure progress. ALCON is dedicated to advancing a future where the opportunity to protect, restore or enhance vision is available to everyone, including our U.S. military and military veterans. In 2024 alone, AI.CON sold more than 52,000 vision correction lenses to the U.S. Department of Defense and other U.S. government entities through government contracts. Alcon's commitment to the United States and its local communities is illustrated by ALCON 's Children Vision Program a program that works with local school districts to provide no-cost comprehensive exams and glasses for students. As part of this program, ALCON AODC provides free vision screenings for students in Cabell County, West Virginia, including 2,472 student screenings in 2024 alone. The ALCON AODC North Facility is located on a 2I-acre industrial park in a rural community, surrounded by industry, a sewer plant, and warehouses. It is located adjacent to what will become an ALCON warehouse at 1 Vision Lane which is located on a separate 26-acre parcel. The ALCON AODC North Facility manufactures Intraocular Lenses (10Ls) and 1OL delivery devices. An 10I, is a tiny, artificial lens for the eye, which replaces the eye's natural lens that is removed during cataract surgery. AI.CON's 10I, portfolio reflects a strong legacy of eye care innovation based on AI.CON's significant strategic commitment to research and development. Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00002 SC_EVERSPLIT0012433 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 3 Presidential Exemption Request A. AODC's Current Sterilization Process Is Uniquely Designed to Minimize Ethylene Oxide Emissions As surgical implantable devices, 10I.s must he carefully sterilized. The AI.CON AODC facility is an existing minor source facility which operates three (3) identical EtO sterilization chambers that are uniquely designed to minimize EtO emissions generated during the sterilization process. IOLs are sterilized in these chambers inside their primary Tyvek pouch packaging, using metal racks with three (3) plastic pallets per chamber. Unlike many EtO sterilization facilities, no cardboard or paper is used in AODC's sterilization process, which reduces residual EtO emissions after sterilization. Loading and unloading for each sterilization chamber is also automated, reducing potential employee exposure to EtO. After sterilization, the 10I.s (in their primary Tyvek pouch packaging) are transferred by enclosed mechanized conveyer into a 24-hour aeration chamber. The facility utilizes a Lesni Abatement Plant (water balancer and catalytic oxidizer) to treat the sterilization chamber vents (SCVs) and aeration room vents (ARVs). The facility has no chamber exhaust vents (CEVs). The aeration cells utilize exhaust air from the unloading area for makeup, and the aeration cell vents are routed to a low concentration inlet of the Lesni Abatement Plant. Both vent sources are routed through a single stack to the atmosphere. After aeration, the 10I.s are transported to a final Packaging and Labeling Area, where they are placed into cartons with tamper seals and placed in shipper boxes. Most commercial sterilizers sterilize products in their final packaging, which includes a lot of materials that will retain EtO and create longer aeration and/or more fugitive off-gassing downstream in trucks and distribution warehouses. AODC's sterilization process is uniquely designed to reduce aeration time and fugitive emissions in the off-gassing process thereby reducing emissions and risks to public health. B. AODC's Current Eth ylene Oxide Process Controls Are Already Highly Effective At the present time, the ALCON AODC facility uses less than five tons of EtO on an annual basis. Moreover, the unique design of AODC's sterilization process is highly effective at reducing EtO emissions. Total emissions from the AODC facility after existing controls already meet the requirements of the pre-2024 NESIIAP regulations. Stack tests were conducted in 2019 by AI,CON on the I.esni Abatement Plant stack and observed by the West Virginia Department of Environmental Protection, Division of Air Pollution Control. During the most recent testing, the I.esni Abatement Plant achieved an average destruction and removal efficiency (DRE) that exceeded 99.8%. Consequently, EtO stack emissions at AODC are extremely low. ALCON has been in Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00003 SC_EVERSPLIT0012434 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 4 continuous compliance with the pre-2024 NESHAP regulations and has never been cited for violations of the applicable regulations. AODC also engaged the leading provider of enhanced optical spectroscopy analytical solutions to conduct an Ethylene Oxide Workplace Exposure Site Evaluation between August 12 and September 6, 2024. The independent assessment company conducted continuous sampling at 17 locations throughout the facility over 26 days utilizing a Workplace Monitoring System (WMS). During the period of analysis, no position within the facility exceeded a 1ppm/8hr timeweighted-average (TWA) permissible exposure limit (PEL) under normal conditions. The largest 8hr TWA was 0.139 ppm. The sanie company noted in its final report that the EtO sampling recorded values at AODC were the lowest they had seen in any facility based on their extensive monitoring experience. In addition. the EPA evaluated the cancer maximum individual risk (MIR) from ALCON's AODC facility in January 2024. See Residual Risk ASSe.vsmeni for the CommerciaTS'ierilization Facilities Source Category in Support of the 2024 Risk and Technology Review Final Rule at Table 2a-1. The facility-wide cancer MIR for AODC in the EPA's evaluation was very low at 0.2-in-1 million far below the 1-in-1 million cancer risk the Et0 NESHAP Rule sets as a target. C. Challenges Presented by the EtO NESHAP Rule The April 5, 2024, Et0 NESIIAP Rule presents many technological, engineering and business challenges for AI,CON. To comply with this revised rule, AI.CON continues to research, design, plan, and consider: (1) product disruptions, (2) capacity reductions, (3) alternative compliance options such as off-shoring production, or out-sourcing sterilization, (4) development of new engineering design plans, and (5) vendors to provide the required PTE, CF.Ms, and new control systems. The first three options for AODC compliance with the Et0 NESHAP Rule product disruptions, capacity reductions, or off-shoring 1 out-sourcing production -- are problematic for the domestic and national security reasons discussed below. I. Limitation of Technology and Expertise ALCON continues to research technologies and suppliers to achieve the applicable NESHAP requirements without negatively impacting its IOL manufacturing at the AODC facility. This research and review has included contacting engineering firms familiar with designing sterilization facilities and Method 204 compliant PTEls and reaching out to current abatement and Et0 monitoring vendors, colleagues in the industry, and trade organisations. Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00004 SC_EVERSPLIT0012435 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 5 As the April 5, 2024, Et0 NESHAP Rule recognizes and acknowledges, there are limited vendors with the technology and expertise to plan, design, and install the PTEs, the air pollution controls, and the CFMs that are required by the 2024 EtO NESIIAP Rule. See General Information at 89 Fed. Reg. 24090, 24102. AI,CON has and continues to expend significant resources in an attempt to comply with the Rule. ALCON has held onsite meetings and demonstrations with several vendors of CEM equipment that advertise technology meeting the NESIIAP requirements as well as experienced engineering design firms. AI,CON has approved and expended significant Capital funding for a multi-disciplinary design firm to conduct the following for the AODC An EPA Compliance Assessment to understand the NESIIAP applicability to current operations and recommended options for compliance based on the facility's unique layout and challenges. An onsite 25-day Et0 Monitoring Study using industry-approved cavity ring-down spectroscopy technology. This study was selected to better understand the fugitive emissions in Group 1 and Group 2 rooms as well as to afford the site with the opportunity to become familiar with the vendor and their equipment. A Basis of Design (30D) study for the Method 204 PTE of Group 1 and Group 2 Rooms and the Dry Bed Abatement Facility required to support the PTE abatement exhaust. Develop a Rough Order of Magnitude (ROM) Budgetary Cost Estimate for the project. 2. Threat to Sterilization and Quality Control Through this design process, AI.CON has determined that compliance with the EtO NESIIAP Rule threatens the integrity of AODC's sterilization and quality control process. Particulate (dust, hair, etc.) in the final packaging for an implantable medical device is a major risk. To minimize this risk, AODC maintains positive air pressure in its final Packaging and Labeling Area. However, this area is a Group 2 Room that would be required to be converted to a PTE under the revised Et0 NESHAP Rule. Converting this area to a PTE would create a negative air flow into the Packaging and Labeling Area from surrounding rooms (including the facility's main hallway) and potentially contaminate the final packaging for the IOI,s. 3. Inability to Meet Deadline Coupled with Uncertainty Despite ALCON's extensive efforts to find cost-effective solutions to comply with the Et0 NESIIAP Rule, based on the studies and efforts provided above, the estimated cost for AODC to achieve compliance with the Rule at its current FAO usage is greater than 15% of AI,CON AODC's annual operating budget, which is more than 50 times EPA's woefully underestimated cost of compliance for the facility. This exorbitant cost to achieve compliance is particularly Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00005 SC_EVERSPLIT0012436 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 6 challenging given the controversy and litigation surrounding the new Et0 NESHAP Rule. As EPA is aware, EPA announced on March 12, 2025, that it would reconsider the new Et0 NESIIAP Rule as part of a broader deregulatory initiative mandated under Executive Orders signed by President Donald Trump. The U.S. Court of Appeals for the District of Columbia has also scheduled oral arguments to hear from multiple parties challenging the Et0 NESHAP Rule. The Executive Orders, the EPA deregulatory announcements, the ongoing EtO litigation, and the difficulties with timely obtaining an assured supply of technologies and expertise have created fundamental uncertainty as to the scope, timing, and content of compliance requirements. This creates significant uncertainty for companies like ALCON that would need to deploy significant resources to attempt to comply with the Rule without reducing or off-shoring production. Moreover, and more importantly for its purposes, despite AI.CON AODC's significant efforts to achieve compliance with the April 5, 2024, Et0 NESHAP Rule requirements in a timely manner, ALCON is not able to identify and implement technology that will serve its unique needs by the compliance deadlines for the new EtO Rule. For the reasons discussed above (as well as others discussed below), ALCON's AODC facility requests a two-year exemption from the April 5, 2024. Et0 NESHAP Rule, as provided for in Section I12(i)(4) of the Clean Air Act. D. National Security Implications of Compliance with the EtO NESIIAP Rule As a global and world class leading producer of1OLs, it is extremely important that ALCON continue to produce high-quality cataract replacement lenses. Indeed, the ability of ALCON to produce 10I.s is in the national security interests of the United States for several reasons. AI.CON supplies 56% of the US 10I, market and 32% of the global IOI. market. Cataract surgery is one of the most frequently performed surgical procedures. According to the National Eye Institute, cataracts are the leading cause of blindness worldwide even though effective surgical treatment exists. Currently, surgical removal of the clouded lens followed by insertion of an 10L is the preferred treatment for cataracts. The clouded lens is usually removed through a process known as phacoemulsification. During phacoemulsification, an ophthalmic surgeon makes a small surgical incision in the cornea (approximately 2-3 millimeters wide) and inserts an ultrasonic probe that breaks up, or emulsifies, the clouded lens while a hollow needle removes the pieces of the lens. Once the clouded lens is removed, the surgeon inserts an IOI. through the same surgical incision. An Advanced Technology IOL (ATiOL) is a type of IOL that also corrects for refractive errors, like presbyopia and astigmatism. ALCON's AODC facility in West Virginia reduces potential American dependency on imports of 10I,s. In addition to the eye care health crisis potentially associated with IOL product disruptions due to vendor delays, longer production times, packaging modifications, and/or production shutdowns for facility modifications, the United States global leadership in 10I.s is a contributor to the economic stability of this country. It is important that the United States maintains its global leadership in R&D and in advanced manufacturing. ALCON is on the cutting edge of these initiatives in the eye care industry and maintaining and improving the L.S. eye care market Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00006 SC_EVERSPLIT0012437 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 7 contributes to the economic stability of the United States. The economic stability of the United States is in the country's national security interests. Beyond the economic stability justifications for AI.CON's contributions to our nation's national security, ALCON also supplies U.S. military personnel and military veterans with cataract replacement lens. I n 2024 alone, AI,CON sold more than 52,000 vision correction lenses to the U.S. Department of Defense and other U.S. government entities through government contracts. The Defense Health Agency's Vision Center of Excellence (VCF) reports that military service members are more prone to traumatic eye injuries, with 68% occurring on the battlefield and 28% during noncombat work and training. These injuries, often blunt or penetrating, frequently require 10I.s for sight-restoring cataract surgeries. In addition to supporting active duty members, the U.S. Department of Veteran Affairs commonly covers, provides, and performs cataract surgery for qualifying veterans. AODC should be permitted to continue manufacturing and sterilizing high-quality cataract replacement lenses for the U.S. military and military veterans. Conclusion Despite its significant efforts to achieve compliance with the April 5, 2024, Et0 NESHAP Rule requirements in a timely manner, AI,CON is not able to obtain and install the technology required by the new Rule by the compliance deadlines. Attempting to comply with the new Rule would result in several months of manufacturing shutdowns, product shortages, capacity reductions, and the need to explore out-sourcing sterilization of 10I,s to reduce DO usage. This would negatively impact national security by affecting U.S. military and veteran use oflOI,s produced at the AODC facility, as well as the stability of U.S. markets, and potentially leave multiple millions of Americans in the general population dependent on imported IOI.s for their sight. For these reasons, AI,CON Research Ltd., requests a two-year exemption from the April 24, 2024, Et0 NESHAP, as provided for in Section 112(i)(4) of the Clean Air Act. In addition to the federal regulations, the April 5, 2024, Et0 NESHAP has been adopted by reference at W. Va. Code R. 45-34, as a federal counterpart regulation, in accordance with W. Va. Code 22-5-4. Accordingly, AI,CON requests that the two-year exemption equally apply to the West Virginia regulations. Moreover, given the significant resource expenditure that will be required for AODC to attempt to comply with the Rule, the minimal environmental gain given the unique design of the AODC facility, and the potential impacts to AODC's quality control process, ALCON believes the Et0 NFSIIAP Rule should be rescinded as applied to the AODC facility. ALCON also welcomes any future opportunity to provide EPA with the technical information it requires to promulgate a revised Ft NESIIAP Rule that will not negatively impact critical medical devices manufactured and sterilized at the ALCON AODC Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00007 SC_EVERSPLIT0012438 Lee Zeldin, Administrator U.S. Environmental Protection Agency March 31, 2025 Page 8 Thank you for your consideration. Sincerely, Childers, Can Digitally signed by Childers, Candace Date: 2025.0331 14:53:06 -04'00' Candace Childers Vice President, Manufacturing Plant Manager 245 Kyle Lane I Iuntington, WV 25702 com Submitted on behalf of ALCON Research Ltd., ALCON Advance Optic Device Center, North Facility, 2 Vision Lane, Lesage, Cabe!! County, West Virginia 2553 7 cc: Michael Egnor, Air Toxic Coordinator West Virginia Department of Environmental Protection (via electronic mail - and D1.1> \ ) Sierra Club FOIA 2025-EPA-04883 ED_018388_00000059-00008 SC_EVERSPLIT0012439