INFORMATION DATE 19910815
DESCRIPTION USDOL Program Highlights-Ethylene Oxide SUBJECT Ethylene Oxide (EtO)
STANDARD NUMBER 1910.1047
ABSTRACT The ethylene oxide standard was amended April 6, 1988, to reduce the health risk associated with EtO by requiring control of short-term exposure to EtO. Workers primarily employed
by hospitals and medical products manufacturers will benefit most from
the 1988 amendment.
U.S. Department of Labor
Program Highlights
Fact Sheet No. OSHA 91-17
ETHYLENE OXIDE STANDARDS
On June 22, 1984, the Occupational Safety and Health Administration (OSHA) issued a standard which set a limit on worker exposure to ethylene oxide (EtO) averaged over an either hour day to protect about 68,000 workers exposed to the substance. The standard was amended April 6, 1988, to further reduce the health risk associated with EtO by requiring control of short-term exposure to EtO as well. Workers primarily employed by hospitals and medical products manufacturers will benefit most from the 1988 amendment.
Both human and animal studies suggest that EtO is a potential occupational carcinogen, causing leukemia and other cancers. EtO has also been linked to reproductive damage, including spontaneous abortions; cytogenetic damage; neurological effects ranging from nausea, and dizziness to peripheral paralysis; and tissue irritation.
EtO is a colorless gas with an ether-like odor. Most worker exposures occur when EtO is used as a sterilant.
The key provisions to the EtO standard include:
- A limit on workplace exposure of one part EtO per million parts air (1 ppm) averaged over an eight-hour day.
- An excursion limit of five parts EtO per million parts of air (5 ppm) averaged over a sampling period of 15 minutes. Employee rotation is prohibited as a means of compliance with the excursion limit.
Where the excursion limit is exceeded employers must:
- Use engineering controls and work practices to reduce exposure. These controls and practices may be supplemented by the use of respirators where necessary.
- Establish and implement a written compliance program to achieve the excursion limit.
- Establish exposure monitoring and training programs for employees subjected to EtO exposure above the excursion limit.
- Identify as a regulated area any location where airborne concentrations of EtO is expected to exceed the excursion limit.
- Place warning labels on containers capable of releasing EtO to the extent that an employee's exposure would foreseeably exceed the excursion limit.
- Respiratory protection. Respirators can be used to control exposure only in the following circumstances: while feasible engineering and work practice controls are being installed; during maintenance, repair, and other operations for which engineering controls are not feasible; in work situations where feasible engineering and work practice controls do not reduce exposures below permissible exposure limit (PEL); and in emergencies.
- An action level of 0.5 ppm. If the eight-hour time-weighted airborne concentration of EtO is at or exceeds the action level, employers must begin periodic exposure monitoring and medical surveillance. Employers who demonstrate that worker exposures are below the action level need not comply with most provisions of the standard.
- Exposure monitoring. If an employer has not monitored worker exposures within the past year, he or she must do so for each job classification in a work area during each shift; representative sampling is permitted under certain circumstances. The frequency of subsequent monitoring depends on the results of the initial sampling. All monitoring may be observed by workers and their designated representatives.
- Medical surveillance. The standard requires a comprehensive medical surveillance program to be conducted by or under the supervision of a licensed physician. Workers must receive a medical examination: before assignment to an area where exposure is at or above the action level; annually if they are exposed at this level for 30 days or more during the year; upon request, if a worker has developed symptoms suggesting overexposure or wants medical advice concerning the effects of EtO exposure on his or her ability to produce a healthy child; and at the time a worker ends employment in an area of exposure.
- Regulated areas. Employers must identify areas where occupational exposure exceeds the PEL. These areas must be clearly marked and only authorized persons allowed to enter.
- Communication of EtO hazards to employees. Information must be provided to workers through: signs and labels clearly indicating EtO's carcinogenic and reproductive hazards. Information and training must be given initially to workers who may be exposed at or above the action level and at least annually thereafter.
- Recordkeeping. Exposure records must be retained for 30 years; medical records must be kept for the worker's duration of employment plus 30 years. Workers, former employees, and their designated representatives may have access to records, upon request.
- Appendices. The standard contains four nonmandatory appendices: a substance safety data sheet, technical guidelines, medical surveillance guidelines, and sampling and analytical methods.
- Applicability. The standard generally applies to all occupational exposures to EtO. However, workplaces in which the processing, use or handling of products containing EtO cannot result in airborne concentration at or above the action level are excluded. An employer who claims exemption from the standard must keep records that document this determination.
Copies of the standard are available from any OSHA regional office, listed under 'U.S. Labor Department' in phone directories for Boston, New York, Philadelphia, Atlanta, Chicago, Kansas City, Dallas, Denver, San Francisco, and Seattle.
This is one of a series of fact sheets highlighting U.S. Department of Labor programs. It is intended as a general description only and does not carry the force of legal opinion.