Public Citizen Testimony Before OSHA Regarding Ethylene Oxide
By A'Ishah Johnson, MPH, DrPH(c), Public Citizen's Congress Watch
My name is A’Ishah Johnson, the Workers’ Health and Safety Advocate with Public Citizen. Public Citizen is a nonprofit consumer advocacy organization with over one million members and supporters. My work covers a range of worker health and safety issues, including chemical hazards in the workplace, informed by my background in public health and ongoing doctoral studies. Public Citizen has no financial conflicts of interest related to ethylene oxide, respiratory protection, or the issues addressed in this rulemaking.
OSHA proposes to allow employers to replace the full-facepiece respirator currently required with a half-mask when workers are exposed to ethylene oxide, a known carcinogen for which there is no safe level of exposure. It would also remove the clear requirements that currently trigger respirator use. Public Citizen strongly opposes this reduction in worker protections. OSHA has not demonstrated that lowering the standard will adequately protect workers from the serious health risks posed by ethylene oxide.[i]
In April 2024, EPA finalized new limits[ii] on ethylene oxide emissions from sterilization facilities, citing cancer risk to families living near plants such as the one in Willowbrook, Illinois.[iii] In July 2025, the President exempted dozens of those same facilities from that rule for two years.[iv] In March 2026, EPA proposed rescinding the risk-based limits at the center of that rule.[v] Far from undermining the need for stronger protections, recent research has added to the evidence that ethylene oxide poses significant risks to exposed workers.
In May 2025, scientists at NIOSH, a sister agency within the Department of Health and Human Services, published a sixty-two-year mortality study of ethylene oxide sterilization workers.[vi] Women exposed at a cumulative dose equal to ten years at OSHA’s current permissible exposure limit died of breast cancer at more than three times the rate of unexposed workers, a relative risk of 3.15. These findings make OSHA’s decision not to assess risk in this proposal particularly striking.
OSHA makes no finding on risk anywhere in this proposal. The agency states plainly that it is not determining whether significant risk exists and cites Public Citizen Health Research Group v. Tyson for the proposition that no such finding is required.[vii] Tyson held that OSHA need not relitigate a standard’s foundation every time it acts on that standard. It did not hold that OSHA may remove existing protections while offering no evidence that workers will remain adequately protected.
Paragraph (g)(3)(i) currently bars half masks because ethylene oxide is a mutagenic carcinogen with no established safe threshold. OSHA proposes to lift that bar and let a half mask, paired with goggles, substitute for a full facepiece. The numbers do not support that substitution: an air-purifying half mask carries an assigned protection factor of ten, and a full facepiece carries fifty.[viii] Adding goggles does not make a half mask equivalent to a full-facepiece respirator. The proposal simultaneously lowers how rigorously that mask must be verified to fit, from a quantitative fit factor of five hundred down to a subjective taste or smell test.[ix] A respirator that provides less protection, combined with a less rigorous fit-testing method, cannot simply be assumed to provide equivalent protection to workers exposed to a known carcinogen.
OSHA’s own economic analysis estimates that the proposal would save employers approximately $203.75 per affected worker each year, or nearly $189,000 annually across the exposed workforce. At the same time, the agency identifies no evidence that the proposal would improve worker protection in any respect.[x] The proposal not only fails to identify a benefit to worker protection but also removes safeguards that ensure respirators are used when needed.
The proposal also deletes the four paragraphs specifying exactly when a respirator must be worn and replaces them with a cross-reference to the employer’s own judgment.[xi] OSHA focuses on what employers may continue to do. The more important question is what they will no longer be required to do. Specific requirements are harder to ignore, evade, or reinterpret than general ones.
Public Citizen urges OSHA to withdraw these proposed changes and preserve the current respirator requirements. At a time when new evidence continues to raise concerns about the health risks of ethylene oxide exposure, OSHA should be evaluating whether additional protections are warranted, not weakening existing ones.
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[i] Ethylene Oxide, 90 Fed. Reg. 28,307 (proposed July 1, 2025) (Docket No. OSHA-2025-0018; RIN 1218-AD63). https://www.federalregister.gov/documents/2025/07/01/2025-11638/ethylene-oxide
[ii] U.S. EPA, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89 Fed. Reg. 24,090 (Apr. 5, 2024) (reducing ethylene oxide emissions from commercial sterilizers by more than 90 percent). https://www.federalregister.gov/documents/2024/04/05/2024-05905/national-emission-standards-for-hazardous-air-pollutants-ethylene-oxide-emissions-standards-for
[iii] ATSDR, Sterigenics Ethylene Oxide Evaluation, Willowbrook, Illinois (Nov. 13, 2023) (concern for increased lifetime cancer risk for residents within one mile of the facility before it ceased operations in February 2019). https://www.atsdr.cdc.gov/HAC/pha/sterigenic/Sterigenics-Evaluation-Ethylene-Oxid-FS-508.pdf
[iv] Proclamation 10959, Regulatory Relief for Certain Stationary Sources To Promote American Security With Respect to Sterile Medical Equipment, 90 Fed. Reg. 34,747 (July 23, 2025) (two-year Clean Air Act compliance exemption for facilities named in Annex I). https://www.federalregister.gov/documents/2025/07/23/2025-13924/regulatory-relief-for-certain-stationary-sources-to-promote-american-security-with-respect-to
[v] U.S. EPA, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration, 91 Fed. Reg. 12,700 (proposed Mar. 17, 2026) (proposing to rescind the risk-based standards adopted in 2024). https://www.federalregister.gov/documents/2026/03/17/2026-05167/national-emission-standards-for-hazardous-air-pollutants-ethylene-oxide-emissions-standards-for
[vi] Kelly-Reif K, Bertke SJ, Stayner L, Steenland K, Exposure to Ethylene Oxide and Relative Rates of Female Breast Cancer Mortality: 62 Years of Follow-Up in a Large US Occupational Cohort, Environmental Health Perspectives 133(5):057013 (May 22, 2025) (relative risk 3.15, 95% CI 1.78-5.60, at cumulative exposure equivalent to ten years at OSHA’s current 1 ppm permissible exposure limit). https://pubmed.ncbi.nlm.nih.gov/40168621/
[vii] 90 Fed. Reg. at 28,308 (OSHA stating it is not making a preliminary finding of significant risk for this proposed rule). https://www.federalregister.gov/documents/2025/07/01/2025-11638/ethylene-oxide
[viii] 29 C.F.R. 1910.134(d)(3)(i)(A), Table 1 (assigned protection factors: air-purifying half mask, 10; air-purifying full facepiece, 50). https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134
[ix] 29 C.F.R. 1910.134(f)(6)-(f)(7) (qualitative fit testing limited to a fit factor of 100 or less; quantitative fit factor of 500 required for tight-fitting full facepieces). https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134
[x] 90 Fed. Reg. at 28,310 (Economic Analysis) (estimating a difference of $203.75 per employee annually, approximately $189,000 in aggregate annual savings, and asking whether any benefits for worker protection can be anticipated from the change). https://www.federalregister.gov/documents/2025/07/01/2025-11638/ethylene-oxide
[xi] 90 Fed. Reg. at 28,309, 28,311 (proposing to remove paragraphs (g)(1)(i) through (iv) and substitute a cross-reference to 29 C.F.R. 1910.134(a)(2)). https://www.federalregister.gov/documents/2025/07/01/2025-11638/ethylene-oxide