Action level. An airborne concentration of ethylene oxide (EtO) of 0.5 parts per million, calculated as an eight-hour time-weighted average.

Authorized personnel. Individuals specifically permitted by the employer to enter the exposure control area to perform necessary duties, or to observe employee exposure evaluations.

Breathing zone. The space around and in front of an employee's nose and mouth, forming a hemisphere with a six- to nine-inch radius.

CAS (Chemical Abstract Service) number. CAS numbers are internationally recognized and used on safety data sheets (SDSs) and other documents to identify substances. For more information see http://www.cas.org/about.

Container. Any container, except for pipes or piping systems that contains ethylene oxide. It can be any of the following:

(a) Barrel.

(b) Bottle.

(c) Can.

(d) Cylinder.

(e) Drum.

(f) Reaction vessel.

(g) Storage tank.

Day. Any part of a calendar day.

Director. The director means the director of the department of labor and industries or their designee.

Emergency. Any event that could or does result in the unexpected significant release of ethylene oxide. Examples of emergencies include equipment failure, container rupture, or control equipment failure.

Ethylene oxide (EtO). Is an organic chemical represented by the CAS registry number 75-21-8. EtO is a flammable colorless gas and is commonly used to sterilize medical equipment and as a fumigant for certain agricultural products. It is also used as an intermediary in the production of various chemicals such as ethylene glycol, automotive antifreeze, and polyurethane.

Exposure. The contact an employee has with ethylene oxide, whether or not protection is provided by respirators or other personal protective equipment (PPE). Exposure can occur through various routes of entry such as inhalation, ingestion, skin contact, or skin absorption.

Licensed health care professional (LHCP). An individual whose legally permitted scope of practice allows him or her to provide some or all of the health care services required for medical evaluations.

Permissible exposure limits (PELs). PELs are employee exposures to toxic substances or harmful physical agents that must not be exceeded. PELs are specified in applicable WISHA rules. The PELs for ethylene oxide (EtO) are:

(a) Eight-hour time-weighted average (TWA8) of one part per million (ppm); and

(b) Fifteen-minute short-term exposure limit (STEL) of five ppm.

Short-term exposure limit (STEL). An exposure limit averaged over a short time period (usually fifteen minutes) that must not be exceeded during any part of an employee's workday.

Time-weighted average (TWA8). An exposure limit averaged over an eight-hour period that must not be exceeded during an employee's workday.

This chapter applies to all occupational exposure to ethylene oxide.

Ethylene oxide (EtO). An organic chemical represented by the Chemical Abstract Service (CAS) registry number 75-21-8. It is a flammable colorless gas that is commonly used to sterilize medical equipment and as a fumigant for certain agricultural products. It is also used as an intermediary in the production of various chemicals such as ethylene glycol, automotive antifreeze, and polyethylene.

Exposure. The contact an employee has with EtO, whether or not protection is provided by respirators or other personal protective equipment (PPE). Exposure can occur through various routes of entry such as inhalation, ingestion, or skin and eye contact.

Some of the requirements in this chapter may not apply to every workplace with an occupational exposure to EtO. The following steps will show which requirements apply to your workplace based on employee exposure monitoring results.

To evaluate employee exposure and protect employee from ethylene oxide.

• The requirements in basic rules apply to all employers covered by the scope of this chapter, WAC 296-855-100. Additional sections may apply to you, based on employee exposure monitoring results. Turn to the Scope, WAC 296-855-100, and follow Table 1.

(1) You must make sure that all containers of EtO whose contents are capable of causing employee exposure above the action level or above the STEL are labeled, tagged, or marked with this warning, stating that breathing airborne concentrations of EtO is hazardous.

(2) You must keep container labels free of statements that contradict or detract from the labels' hazard warning.

(3) You must make sure warning labels remain on containers of EtO when these containers are transported.

(1) You must establish temporary or permanent exposure control areas where airborne concentrations of ethylene oxide (EtO) exceed or could exceed the permissible exposure limits (PELs) by doing all the following:

(a) Clearly identify the boundaries of exposure control areas in any way that minimizes employee access.

(b) Post signs at access points to exposure control areas that:

(i) Are easy to read (for example, they are kept clean and well lit); and

(ii) Include this warning:

(2) You must keep signs and areas near them free of statements that contradict or detract from their message.

(3) You must allow only authorized personnel to enter exposure control areas.

(4) You must make sure employees entering exposure control areas have appropriate respirators available for use.

(5) You must prevent all of the following activities from occurring in exposure control areas:

(a) Eating food.

(b) Drinking beverages.

(c) Smoking.

(d) Chewing tobacco or gum.

(e) Applying cosmetics.

(f) Storing food, beverages, or cosmetics.

(1) You must make sure employees wear appropriate PPE as protection from skin or eye contact with ethylene oxide (EtO), liquid EtO, or EtO solutions.

(2) You must provide appropriate PPE at no cost to employees.

This section applies when there is a potential for airborne exposure to ethylene oxide (EtO) in your workplace.

When you conduct an exposure evaluation in a workplace where an employee uses a respirator, the protection provided by the respirator is not considered.

Following this section will also meet the requirements to identify and evaluate respiratory hazards found in chapter 296-841 WAC, Airborne contaminants.

(1) You must conduct an employee exposure evaluation to accurately determine airborne concentrations of EtO by completing Steps one through seven of the exposure evaluation process, each time any of the following apply:

(a) No evaluation has been conducted.

(b) Changes have occurred in any of the following areas that may result in new or increased employee exposures:

(i) Production.

(ii) Processes.

(iii) Personnel.

(iv) Exposure controls such as ventilation systems or work practices.

(c) You have any reason to suspect new or increased employee exposure may occur.

(2) You must provide affected employees and their designated representatives an opportunity to observe any exposure monitoring during Step six of the exposure evaluation process.

(3) You must make sure observers entering areas with EtO exposure:

(a) Are provided with and use the same protective clothing, respirators, and other personal protective equipment (PPE) that employees working in the area are required to use; and

(b) Follow all safety and health requirements that apply.

(1) You must provide written notification of exposure monitoring results to employees represented by your exposure evaluation, within five business days after monitoring results become known to you.

(2) In addition, when employee exposure monitoring results are above either the TWA8 or STEL permissible exposure limit (PEL), you must provide written notification of all the following within fifteen business days after the results become known to you:

(a) Corrective actions being taken and a schedule for completion; and

(b) Any reason why exposures can not be lowered to below the PELs.

(1) You must establish and keep complete and accurate records for all exposure monitoring evaluations conducted under this chapter. Make sure the record includes, at least:

(a) The name, unique identifier, and job classification of:

(i) The employee sampled; and

(ii) All other employees represented by the sampled employee.

(b) A description of the methods used to obtain exposure monitoring results and evidence of the methods' accuracy.

(c) The operation being monitored for employee exposure to EtO.

(d) A description of the procedure used to obtain representative employee exposure monitoring results.

(e) The date, number, duration, location, and the result of each sample taken.

(f) Any environmental conditions that could affect exposure concentration measurements.

(g) Any personal protective equipment (PPE) worn by the employee including the type of respirator.

(2) You must keep exposure monitoring records for at least thirty years.

(1) You must keep documentation you develop, of the processing, use, or handling of products made from or containing EtO, that conclusively demonstrates that the action level or STEL for EtO cannot be exceeded under any foreseeable conditions of use.

(2) You must include the following in the documentation record:

(a) The product that is the subject of the documentation;

(b) The source of the data;

(c) Any testing protocol, results of testing, and/or analysis of the product for the release of EtO;

(d) A description of the operation where the product is used and how the data support your conclusion; and

(e) Other data relevant to the operations, materials, processing, or employee exposures covered by your conclusion.

(3) You must maintain the documentation record for as long as you rely on your conclusion that the action level and STEL cannot be exceeded.

(1) You must train employees who are potentially exposed above the:

(a) Action level (AL) 0.5 parts per million (ppm); or

(b) Fifteen-minute short-term exposure limit (STEL) of five ppm.

(2) You must provide training:

(a) At the time of initial assignment; and

(b) Then at least every twelve months.

(3) You must make sure training and information includes all of the following:

(a) The requirements of this chapter.

(b) The location and availability of this chapter.

(c) The purpose of medical evaluations and a description of your medical evaluation program required in Medical evaluations, WAC 296-855-30030 in this chapter.

(d) Monitoring procedures and observations to detect the presence or release of EtO.

(e) The physical and health hazards of EtO.

(f) Actions employees can take to protect themselves from EtO exposure such as work practices, emergency procedures, and PPE.

(g) The details of your hazard communication program required by another chapter, Hazard communication, chapter 296-901 WAC.

(h) Operations in employee work areas where EtO is present.

(i) The following information found in the General occupational health standards, chapter 296-62 WAC:

(i) The Substance safety data sheet, WAC 296-62-07383 Appendix A.

(ii) The Substance technical guidelines, WAC 296-62-07385 Appendix B.

(iii) Medical surveillance guidelines, WAC 296-62-07387 Appendix C.

To monitor employee health and workplace exposures to ethylene oxide (EtO).

These sections apply when employee exposure monitoring results are either above the:

1. Action level (AL) of 0.5 parts per million (ppm); or

2. Short-term exposure limit (STEL) of five ppm.

You must obtain employee exposure monitoring results according to the frequency specified in Table 2, Periodic Exposure Evaluation Frequencies.

Medical evaluations meeting all requirements of this section will fulfill the medical evaluation requirement found in another chapter, Respirators, chapter 296-842 WAC.

Employees who wear respirators need to be medically evaluated to make sure the respirator will not harm them, before they are assigned work in areas requiring respirators.

(1) You must make medical evaluations available to current employees:

(a) Who have been, are, or may be exposed above the action level (AL) for at least thirty days in any twelve-month period.

(b) Exposed to EtO during an emergency situation.

(c) Wanting medical advice on EtO exposure and reproductive health.

(d) Whenever the employee develops signs and symptoms commonly associated with ethylene oxide.

(e) At no cost including travel costs and wages associated with any time spent obtaining the medical evaluation.

(f) At reasonable times and places.

(2) You must complete Steps one through four of the medical evaluation process at the following times:

(a) Initially, when employees are assigned to work in an area where exposure monitoring results are, or will likely be, above the action level (AL) for at least thirty days in a twelve-month period.

(b) Every twelve months for employees exposed above the AL for at least thirty days in the preceding year unless the examining physician determines that they should be provided more frequently.

(c) When employment with exposure ends, if the employee has not had an evaluation within the six-month period before exposure ends.

This section applies when a medical evaluation is performed, or any time a medical record is created for an employee exposed to ethylene oxide (EtO).

(1) You must establish and maintain complete and accurate medical records for each employee receiving a medical evaluation for EtO and make sure the records include all the following:

(a) The employee's name and unique identifier.

(b) Any employee medical complaints related to EtO.

(c) A description of the employee's duties.

(d) A copy of the licensed health care professional's (LHCP's) written opinions.

(e) The anticipated or representative employee exposure monitoring results provided to the LHCP for the employee.

(f) A copy of the information required in Step two of the medical evaluation process, found in WAC 296-855-30030, except the copy of this chapter and the appendices.

(2) You must maintain medical records for the duration of employment plus thirty years.

To protect employees from exposure to ethylene oxide (EtO) by using feasible exposure controls and appropriate respirators.

These sections apply when employee exposure monitoring results are above either of the following permissible exposure limits (PELs):

1. The eight-hour time-weighted average (TWA8) of one part per million (ppm); or

2. The fifteen-minute short-term exposure limit (STEL) of five ppm.

(1) You must establish and implement a written exposure control plan to reduce employee exposure to EtO below both TWA8 and the STEL by the use of feasible exposure controls. Include at least the following in your plan:

(a) A schedule for periodic leak detection surveys.

(b) Make sure employee rotation is not included as a method to control employee exposure.

(2) You must establish a written plan for emergency situations for each work area where there is a possibility of an emergency from a release of EtO. The plan must include, at a minimum:

(a) Emergency escape:

(i) Procedures.

(ii) Route assignments.

(b) Emergency evacuation plans and procedures to account for all employees after emergency evacuation has been completed.

(c) Procedures to be followed by employees who remain to operate critical plant operations before they evacuate.

(d) Requirements for the use of respiratory protection as required in WAC 296-855-40040.

(e) Rescue and medical duties for those employees who will perform them.

(f) The preferred means of reporting fires and other emergencies.

(g) Names or regular job titles of persons or departments who can be contacted for further information or explanation of duties under the plan.

(3) You must establish an employee alarm system that meets the requirements of Employee alarm systems, WAC 296-800-31070 in the safety and health core rules.

The employee alarm system must be distinctive and recognizable as a signal to perform actions designated under the emergency response plan.

(4) You must review your exposure control plan at least every twelve months and update as needed to reflect your current workplace conditions.

(5) You must provide a copy of your exposure control plan to affected employees and their designated representatives, when they ask to review or copy it.

The use of an employee rotation schedule to control employee exposure to ethylene oxide (EtO) is prohibited.

Respirators and other personal protective equipment (PPE) are not exposure controls.

(1) You must use feasible exposure controls to reduce exposure to, or below, the permissible exposure limit (PELs); or

(2) You must reduce exposure to the lowest achievable level above the PELs.

The requirements in this section are in addition to the requirements found in another chapter, Respirators, chapter 296-842 WAC.

Medical evaluations meeting all requirements of WAC 296-855-30030, will fulfill the medical evaluation requirement found in another chapter, Respirators, chapter 296-842 WAC.

(1) You must provide each employee with an appropriate respirator that complies with the requirements of this section, and require that employees use them in circumstances where exposure is above either PEL, such as when:

(a) Feasible exposure controls are being put in place.

(b) Employees conduct work operations such as maintenance and repair activities or vessel cleaning for which exposure controls are not feasible.

(c) Feasible exposure controls do not reduce exposures to or below the PELs.

(d) Employees are responding to emergencies.

(2) You must ensure all respirator use is accompanied by eye protection either through the use of full-facepiece respirators, hoods, or chemical goggles.

(3) You must develop, implement, and maintain a respirator program that meets the requirements of another chapter, Respirators, chapter 296-842 WAC, which covers each employee required by this chapter to use a respirator.

(a) You must select and provide to employees appropriate respirators according to this section and WAC 296-842-13005 in the respirator rule.

(b) You must limit selection and use of respirators, including escape respirators, to those with a full-facepiece or another type of respirator providing eye protection. This is necessary to prevent eye irritation or injury from EtO exposure.

(c) You must equip full-facepiece air-purifying respirators, including escape respirators, with a front- or back-mounted canister certified for protection against ethylene oxide.

Hazard communication—General.

(1) Chemical manufacturers, importers, distributors and employers must comply with all requirements of the Hazard Communication Standard (HCS), chapter 296-901 WAC for EtO.

(2) In classifying the hazards of EtO at least the following hazards are to be addressed: Cancer; reproductive effects; mutagenicity; central nervous system; skin sensitization; skin, eye and respiratory tract irritation; acute toxicity effects; and flammability.

(3) You must include EtO in the hazard communication program established to comply with the HCS, chapter 296-901 WAC. Employers must ensure that each employee has access to labels on containers of EtO and to safety data sheets, and is trained in accordance with the requirements of HCS and WAC 296-855-20090.