OSHA's Ethylene Oxide ICR Just Showed a One-Third Drop in Periodic Medical Exams. Here's What That Means For Your 1910.1047 Program

If you run EHS or industrial hygiene at a commercial sterilizer, a contract sterilizer, an in-vitro diagnostic plant, or a specialty chemical site that uses ethylene oxide as a feedstock, the May 8, 2026 Federal Register has something you need to read before the July 7 comment deadline. OSHA’s information collection request (ICR) for the ethylene oxide standard at 29 CFR 1910.1047 is up for OMB renewal under control number 1218-0108. The number that should stop you is the burden-hour figure: 24,521 hours across 2,123 respondents (91 FR / FR Doc. 2026-09116). That is roughly a third lower than the historical ICR baselines that ran 36,500 to 43,991 hours through the 2003 and 2020 renewal cycles (2003 ICR extension, 88 FR 70516 reference).

That decline tells two stories. One is good news: alternative sterilization methods, hospital phase-outs of in-house EtO chambers, and consolidation of contract sterilization have legitimately removed exposure scenarios at some facilities. The other story is the one OSHA inspectors will go looking for over the next 18 months: facilities that still use EtO, still have employees over the action level for 30 or more days a year, but are no longer running annual medical exams or biannual exposure monitoring because someone decided the program was costing too much. The 2026 ICR data does not tell us which side of that line each facility is on. An inspector showing up at the loading bay of a sterilizer will tell you in about ten minutes.

What 1910.1047 Actually Triggers Medical Surveillance — And Why So Many Facilities Get the Math Wrong

Most safety managers can recite the OSHA ethylene oxide permissible exposure limit: 1 ppm as an 8-hour time-weighted average, with a 5 ppm short-term exposure limit over any 15-minute period (1910.1047(c)). What gets missed is the action level. The action level is 0.5 ppm as an 8-hour TWA — half the PEL — and it is the trigger that pulls in the rest of the standard.

Once a facility has employees exposed at or above 0.5 ppm for 30 or more days per year, the employer must establish a medical surveillance program under 1910.1047(i). The program is not optional, it is not waivable by the employee, and it is not satisfied by general OSHA-mandated physicals required under other standards. It must include:

A pre-placement examination before the employee is first assigned to EtO work
A periodic examination at least annually
A medical and work history with attention to pulmonary, hematologic, neurologic, and reproductive systems plus eyes and skin
A physical examination focused on those same systems
A complete blood count — white cell count with differential, red cell count, hematocrit, and hemoglobin (confirmed mandatory by OSHA’s 2017 standard interpretation)
Examination after any emergency exposure
Termination or reassignment examination
A written medical opinion delivered to the employer

The 30-day count is calculated cumulatively across the year — five days a week for six weeks gets a pretty large fraction of a sterilizer’s central processing crew over the line. The trigger is the expected exposure based on the initial determination, not whether the employee personally requested an exam. And the trigger does not care about respirator use. An employee wearing a powered air-purifying respirator over 0.5 ppm for 30 days is still in the surveillance program.

Where facilities get the math wrong is in the initial exposure determination under 1910.1047(d). A sterilizer chamber with engineering controls in good order produces low cycle-average concentrations. But the worker exposure that drives the action level is not the chamber average — it is the door-opening transition, the aeration room work, the maintenance access, and the leak events. Industrial sterilization workers in the OSHA workplace-investigation dataset show a median EtO exposure of 0.4061 ppm (PMC peer-reviewed analysis) — already most of the way to the action level for a single shift. Add a few door-opening events and you are over.

What the 2026 ICR Decline Actually Says About Compliance Activity

OSHA’s ICR submission under OMB 1218-0108 estimates the paperwork and procedural burden of complying with 1910.1047. It includes exposure monitoring, medical surveillance, recordkeeping, training rosters, regulated-area signage, and similar activity. The 2026 estimate is 87,592 responses across 2,123 respondents, totaling 24,521 burden hours and $4,261,393 in operation-and-maintenance costs (2026 ICR notice).

Compare that to the prior cycles where OSHA’s burden-hour estimates ran in the 36,500 to 43,991 range. The drop in the 2026 estimate is consistent with a roughly one-third reduction in the periodic-exam-driven activity that was previously in the count.

How much of that decline is real?

EtO sterilization volume has consolidated. Hospitals that ran in-house EtO chambers for surgical instrument processing have substantially shifted to vaporized hydrogen peroxide and steam where the device manufacturer instructions allow it. That removes affected employees from the count.
Commercial sterilizers consolidated. Roughly 90 facilities operated by about 50 companies handle approximately 50% of U.S. medical devices and about 20 billion devices a year (EPA NESHAP background). Some legacy sites closed when the 2024 NESHAP RTR final rule came into force, removing those workers from the affected pool.
Some facilities replaced EtO with electron beam, gamma, or hydrogen peroxide for product lines where validation supports the switch.

That is the legitimate part of the decline. The part that is not legitimate is facilities that still use EtO, still have central processing employees over the action level for 30+ days per year, and have quietly let the annual medical surveillance program lapse because the program manager left or the renewal contract with the occupational medicine clinic was not renewed. Those facilities are not visible in the ICR — but they are visible in an inspection.

How the EPA NESHAP Reconsideration Affects (And Doesn’t Affect) Your OSHA Program

Three months before the OSHA ICR notice, EPA published a separate proposed reconsideration of the 2024 NESHAP for Commercial Sterilization Facilities. That action proposes to rescind or revise several of the most stringent 2024 amendments under 40 CFR Part 63 Subpart O. EPA held a virtual hearing April 1, 2026 with comments closing May 1, 2026.

A separate iSi post covers the EPA reconsideration in detail. For the OSHA-side question, the key point is this: the EPA NESHAP reconsideration changes what comes out of your stack and your aeration room vents. It does not change 1910.1047. Worker exposure to EtO is driven primarily by chamber door-opening, sterilized-load transfer, aeration room work, and maintenance — not by stack emissions. A facility could see lower stack emissions under a reconsidered NESHAP, lower ambient air monitoring readings around the property line, and yet still have central-processing operators over the 0.5 ppm action level for far more than 30 days a year.

In practice, a 2026 OSHA inspection of a commercial sterilizer is more likely, not less, after EPA enforcement activity at the same site. Inspectors triangulate. EPA finds an emissions excursion, OSHA referrals follow, and the inspection looks first for the items that prove the medical surveillance program is current.

The 1910.1047 Inspection Sequence: What An Inspector Will Pull First

For EHS and IH managers reading this who want to self-audit before any external trigger arrives, this is the order an OSHA compliance officer typically asks for documents during an EtO inspection:

The written EtO compliance program — under 1910.1047(j), employers exposing employees at or above the action level must maintain a written program. Surprisingly common to find facilities cannot produce a current one.
The initial exposure determination — sample data, calculations, dates, methods.
Periodic monitoring records — every 6 months at the action level, every 3 months at the PEL. Discontinuation only after two consecutive sub-action-level readings 7+ days apart.
The medical surveillance roster — every employee at or above the action level for 30+ days/year, with the date of last periodic examination.
Written medical opinions — one per employee per cycle, signed, on file. Missing opinions are common citation items.
Training records — initial and annual refresher, signed by employees.
Regulated area signage and access controls.
Respiratory protection program records integrated with 1910.134 (fit testing, medical clearance for respirator use, cartridge change schedule).

Penalty exposure under 29 CFR 1903.15 and the January 15, 2025 inflation adjustment carrying into FY 2026:

Serious / Other-than-Serious: up to $16,550 per violation
Willful: minimum $11,823, maximum $165,514 per violation
Repeated: up to $165,514 per violation

A 1910.1047 inspection that finds expired periodic exams across a 20-employee central-processing crew can stack 20 separate citations. Failure-to-monitor is a separate item per affected employee. A single willful citation tied to a documented prior warning carries a maximum penalty of $165,514. Against that exposure, a budget-neutral industrial hygiene assessment that catches a lapsed surveillance program before the inspector does runs in the low four figures. One willful EtO citation costs roughly the same as forty IH assessments — a 41:1 return on the call you make this quarter versus the one you take after the inspection notice arrives.

State Plan Variations Worth Verifying

For facilities in state-plan states, the federal text is not the citation that matters in court. Cal/OSHA enforces 8 CCR 5220, which mirrors the federal 1 ppm 8-hour TWA and 5 ppm STEL but is enforced by the state with separate citation authority and California’s own penalty schedule. Michigan, Washington, Oregon, North Carolina, Virginia, and Minnesota state plans similarly adopt 1910.1047-equivalent text with state-specific citation language. State air agencies in Illinois, Georgia, and California also impose ambient-air monitoring around commercial sterilizers — none of which displaces the worker-side surveillance obligation.

The practical implication for a multi-site operator with EtO sterilization in California, Michigan, and Texas: three state-plan citation paths, three different penalty schedules, one underlying obligation. Verify the surveillance program against the state plan citation, not just the federal text.

What To Do Before The July 7, 2026 Comment Deadline

For EHS managers and IH practitioners, the immediate action items break into 60-day work and 12-month work.

In the next 60 days, before the ICR comment period closes July 7, 2026:

Pull the medical surveillance roster. Confirm every employee currently at or above the action level for 30+ days/year has a periodic exam dated within the last 12 months and a written medical opinion on file.
Confirm the initial exposure determination is current — defined as dated within the last cycle of process changes, equipment retrofits, or production volume shifts. If a sterilizer chamber, aeration room, or load-handling protocol changed in the last 18 months, the determination needs a refresh.
Pull the periodic monitoring records and confirm the frequency matches the highest exposure tier on file (every 6 months at action level, every 3 months at PEL).
Verify training records include the annual refresher and that signatures match the current employee roster.

In the next 12 months:

Schedule a third-party industrial hygiene assessment of the 1910.1047 program — exposure determinations, monitoring frequency, surveillance roster, written program, training, regulated areas, signage. This is the same review an OSHA compliance officer runs.
Build the OSHA-EPA crosswalk into your annual compliance calendar so a NESHAP enforcement event at the corporate level triggers an automatic surveillance program audit at the affected site.
Confirm the state plan citation language for any non-federal-OSHA state where the company operates EtO sterilization.

This is the kind of work iSi’s industrial hygiene practice handles every week — exposure determinations, medical-surveillance program audits, regulated-area documentation, written compliance programs, and the IH report that goes back to the EHS manager with a punch list of what needs fixing before the next inspection. Replacing this scope with a full-time environmental hire would cost a manufacturer $130,000 to $195,000 annually in salary and burden alone. iSi delivers a 1910.1047 program audit and follow-up monitoring through the EHS COOP retainer for a fraction of that cost, with a national team across 40 states and no headcount commitment.

If you operate EtO sterilization or use EtO as a process feedstock and your last 1910.1047 surveillance audit was more than 24 months ago, the question is not whether your program has gaps. It is which gaps an inspector will find first. Call (316) 264-7050 or schedule an industrial hygiene assessment before the EPA reconsideration outcomes set the next inspection wave in motion.