OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.


January 8, 1987

Ms. Nikki Peden
Safety Regulatory Manager
HCA Partenon Insurance Company
One Park Plaza
Post Office Box 550
Nashville, Tennessee 37202-0550

Dear Ms. Peden:

This is in response to you letter of November 17, 1986 regarding an interpretation of the ethylene oxide standard, 29 CFR 1910.1047. Please accept my apology for the delay in responding to your request.

Your specific question related to a means of alerting employees during an EtO emergency situation in hospitals, 29 CFR 1910.1047(h)(2).

OSHA defines an EtO emergency situation as "an occurrence such as but not limited to equipment failure, rupture of containers, or failure of control equipment that may result in an unexpected significant release of EtO sufficiently to produce acute toxic effects in exposed employees constitute such an emergency."

29 CFR 1910.1047(h)(1) requires written plans for emergency situations to be developed for each workplace where there is a possibility of an emergency. These plans shall be written in accordance with 29 CFR 1910.38 (Employee emergency action plans and [29 CFR 1910.39] fire prevention plans.)

Section (h)(2) of the standard requires some method of alerting employees of an emergency promptly. OSHA gives the employer the flexibility to choose any effective method of alerting employees including communication systems, voice communication system, or a bell or other alarm. However, if the employer choose to install an emergency alarm system, the system must meet the requirements of 29 CFR 1910.165 (Employee alarm system). It should be mentioned that 29 CFR 1910.165(b)(5) states the following:

For those employers with 10 or fewer employees in a particular workplace, direct voice communication is an acceptable procedure for sounding the alarm provided all employees can hear the alarm.

Therefore, such sophisticated alarm systems might be unnecessary for some facilities such as small hospitals with only one EtO sterilizer.

If we can be of further assistance regarding this matter, please feel free to contact us.


John B. Miles, Jr., Director
Directorate of Field Operations


November 17, 1986

John Miles
Director of Field Operations
200 Constitution Avenue
Room N-3603
Washington, D.C. 20210

Dear Mr. Miles:

On November 14, 1986 I spoke with Jackie Rogers regarding the "means of alerting employees to evacuate during an EtO emergency situation in hospitals." She was extremely helpful.

I would like to obtain a Standard Interpretation Directive on this issue for hospitals. My question is "Are hospitals required to install continuous monitoring systems with audible alarms for emergency situations?"

As a former Compliance Office, I believe such would not be beneficial for the healthcare employee. Bob Manware and I discussed this issue when the standard was published and he agreed that it would not be necessary or practical for hospitals. I believe Ms. Rogers also agreed.

In the hospital industry our present situation is one of manufacturers/suppliers attempting to take advantage of our general lack of knowledge about OSHA's requirements.

It is evident that many statements, implication, etc., being disseminated by salesmen are not in line with what is required regarding EtO management.

For example, one company is utilizing 1910.165 to intimidate hospitals into the purchase of such a system. (A similar system is being promoted by another company at a cost of $25,000.) I have enclosed their brochure as an attachment.

As Jackie pointed out, the preamble states, "The performance language of the emergency situation paragraph of the final standard will give employees the flexibility to choose any effective method of alerting employees, including communication systems, voice communication, or a bell or other alarm."

In accordance with OSHA's definition for an EtO "Emergency" it means any occurrence such as, but not limited to, equipment failure, rupture of containers or failure of control equipment that is likely to or does result in an unexpected significant release EtO." In addition the preamble includes ". . . that might produce a release of EtO of sufficient size to product significant acute effects, including eye or respiratory irritation.

A hospital employee immediately knows if a cartridge ruptures during installation, or if there is a tankline rupture when changing an EtO cylinder or if the equipment is not functioning properly from review of the recording charts. Companies are "selling" the idea that "small" leaks may go unnoticed for some time. "Small" leaks would not produce "significantly acute effects" or even an 8-hour TWA exposure exceeding the action level in most cases.

Considering the small quantity used in healthcare settings and the relatively controlled environment it seems that the current push for continuous monitors/alarms has little or no benefit for the employee.

A directive from your office is most appreciated on this timely topic.

Thank You!

Best regards,

Nikki Peden
Safety Regulatory Manager