Document rej205Mq1ZM58RkQDENXZ3m6a

ELI E SPICE VIA ELECTRONIC SUBMISSION March 31. 2025 Elite Spice Inc. 7151 Montevideo Rd. Jessup, MD 20794 410-796-1900 RE: Presidential Exemption: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review" (59 FR 24090; April 5, 2024) (Sterilizer Rule) To whom it may concern: Elite Spice, lnc. appreciates the opportunity to submit a request for a Presidential Exemption under section 1 12(i)(4) of the Clean Air Act for the National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review" (59 FR 24090; April 5, 2024) (Sterilizer Rule). Elite Spice, lne. is a privately-held. American-owned spice and seasoning manufacturer headquartered in Jessup. Maryland. With over 35 years of experience in processing spices for the food industry, we are committed to maintaining the highest standards of food safety. Our mission is to supply pure, safe, and wholesome spices to the commercial food manufacturing industry. Emissions standards or limitations subject to the request: National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review" (89 FR 24090; April 5, 2024) (Sterilizer Rule) Facilities and affected sources: Elite Spice operates three facilities two in Maryland and one in Nevada--where we utilize ethylene oxide to sterilize spices, ensuring their safety and quality for our customers. Length of compliance period requested: Elite Spice respectfully requests an extension of 24 months beyond the original compliance deadline of April 5, 2026. J ustification as to why the technology to implement the standard is not available: The NESIIAP proposes several actions that are either infeasible to implement or require a complete restructuring of current spice manufacturers' operations. Regardless, the 18-month timeframe the https www clitcspicc.com' Sierra Club FOIA 2025-EPA-04883 ED_018388_00000143-00001 SC_EVERSPLIT0012511 L L1 E SPICE EPA originally proposed is insufficient to implement the changes needed to comply with the NESHAP. The NESHAP effectively forces the spice industry to cease using EO at the end of the implementation period. Additionally, several spice sterilizers have already left the industry duc to these challenges. These concerns are echoed in the comments submitted by the U.S. Office of Advocacy of the Small Business Administration (NESHAP Dock ID No. EPA-HQ-OPP-20130244 & Docket 1D No. EPA-HQ-OAR-2019-0178). Specifically, issues have been raised regarding the unreasonable compliance period, the challenges posed by overlapping compliance regulations with the PID, and the difficulties associated with retrofitting facilities to accommodate total enclosures. While not classified as a small business, `ye at Elite Spice handle spice sterilization as a small segment of our operations, primarily to ensure the safety of our customers and their consumers. Explanation why an extension is in the national security interests of the United States: In 2013, the FDA published a Draft Risk Profile on the prevalence of pathogens and contaminants in spices, identifying significant microbial risks, particularly Salmonella. The FDA found that nearly 7% of examined spice shipments entering the L.S. were contaminated, and both the FDA and Elite Spice believe this rate is likely underestimated due to sampling methods. Effective microbial reduction treatments are essential to protect consumers from life-threatening foodborne pathogens. The spice industry has relied on Ethylene Oxide for over 70 years as a primary means of mitigating pathogen contamination. Given the limited alternatives, it is critical that EO remains available to safeguard public health and meet FDA safety mandates. Without EO, the industry would struggle to ensure spice safety and would need significant time to evaluate and implement new, effective sterilization technologies. Due to the anticipated challenges in complying with the new NESHAP standards, companies have invested considerable capital and time in researching and developing alternative sterilization technologies that meet food safety standards while reducing reliance on FO. I Iowever, the equipment required for these new technologies has long lead times--often taking 8 to 12 months to deliver as it is designed and manufactured overseas, an additional 4 to 6 months to install, and up to 16 months to validate. This timeline is insufficient to meet the compliance deadline, leaving little time to transition away from FO or fully implement other engineering controls. With the lack of time to implement new controls required by NESI lAP or alternative sterilization technologies, many companies may turn to outsourcing this critical function, often relying on overseas vendors to manage foodborne pathogen risks. While spices may seem minor in the food industry, their widespread use in flavoring a variety of food products means that insufficient treatment could result in large-scale foodborne illness outbreaks, posing a significant public health risk and even a national security threat. https www clitcspicc.com' Sierra Club FOIA 2025-EPA-04883 ED_018388_00000143-00002 SC_EVERSPLIT0012512 EL1 E SPICE For these reasons, we respectfully request that the EPA extend the compliance timeline to allow for a re-evaluation of the NESHAP and Pill regulations. This extension could help prevent foodborne disease outbreaks caused by insufficiently validated technologies or the outsourcing of vital food safety technologies to foreign companies, which could create a public safety vulnerability and potentially endanger the health of the American people. Additionally, it would provide the industry with sufficient time to assess new technologies and ensure that emissions control requirements do not unnecessarily compromise food safety efforts. Ethylene Oxide remains essential to public health by preventing foodborne illnesses. We appreciate EPA's consideration of the information provided and would be happy to answer any additional questions on the matter. Best regards, Amanda Slate Food Safety Process Control Sterilization Manager 7151 Montevideo Rd. Jessup, MD 20794 410.796.1900 Ext. 11256 zisli[tccr clilespicc.coni \\ v`.clitc',.picc.corn https www clitcspicc.com' Sierra Club FOIA 2025-EPA-04883 ED_018388_00000143-00003 SC_EVERSPLIT0012513