- Part Number:1910
- Part Number Title:Occupational Safety and Health Standards
- Subpart:1910 Subpart Z
- Subpart Title:Toxic and Hazardous Substances
- Standard Number:
- Title:Ethylene oxide.
- GPO Source:
Scope and application.
This section does not apply to the processing, use, or handling of products containing EtO where objective data are reasonably relied upon that demonstrate that the product is not capable of releasing EtO in airborne concentrations at or above the action level, and may not reasonably be foreseen to release EtO in excess of the excursion limit, under the expected conditions of processing, use, or handling that will cause the greatest possible release.
Definitions: For the purpose of this section, the following definitions shall apply:
Action level means a concentration of airborne EtO of 0.5 ppm calculated as an eight (8)-hour time-weighted average.
Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.
Authorized person means any person specifically authorized by the employer whose duties require the person to enter a regulated area, or any person entering such an area as a designated representative of employees for the purpose of exercising the right to observe monitoring and measuring procedures under paragraph (l) of this section, or any other person authorized by the Act or regulations issued under the Act.
Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.
Emergency 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 of EtO.
Employee exposure means exposure to airborne EtO which would occur if the employee were not using respiratory protective equipment.
Ethylene oxide or EtO means the three-membered ring organic compound with chemical formula C2 H4 O.
Permissible exposure limits -
8-hour time weighted average (TWA). The employer shall ensure that no employee is exposed to an airborne concentration of EtO in excess of one (1) part EtO per million parts of air (1 ppm) as an 8-hour time-weighted average (8-hour TWA).
Excursion limit. The employer shall ensure that no employee is exposed to an airborne concentration of EtO in excess of 5 parts of EtO per million parts of air (5 ppm) as averaged over a sampling period of fifteen (15) minutes.
Exposure monitoring -
Where the employer has previously monitored for the excursion limit and the monitoring satisfies all other requirements of this sections, the employer may rely on such earlier monitoring results to satisfy the requirements of paragraph (d)(2)(i) of this section.
Monitoring frequency (periodic monitoring).
Termination of monitoring.
If the initial monitoring required by paragraph (d)(2)(1) of this section reveals employee exposure to be at or below the excursion limit, the employer may discontinue excursion limit monitoring for those employees whose exposures are represented by the initial monitoring.
If the periodic monitoring required by paragraph (d)(3) of this section reveals that employee exposures, as indicated by at least two consecutive measurements taken at least 7 days apart, are at or below the excursion limit, the employer may discontinue excursion limit monitoring for those employees whose exposures are represented by such monitoring.
Additional monitoring. Notwithstanding the provisions of paragraph (d)(4) of this section, the employer shall institute the exposure monitoring required under paragraphs (d)(2)(i) and (d)(3) of this section whenever there has been a change in the production, process, control equipment, personnel or work practices that may result in new or additional exposures to EtO or when the employer has any reason to suspect that a change may result in new or additional exposures.
Accuracy of monitoring.
Employee notification of monitoring results.
The employer shall establish a regulated area wherever occupational exposure to airborne concentrations of EtO may exceed the TWA or wherever the EtO concentration exceeds or can reasonably be expected to exceed the excursion limit.
Methods of compliance -
Engineering controls and work practices.
Where the TWA or excursion limit is exceeded, the employer shall establish and implement a written program to reduce exposure to or below the TWA and to or below the excursion limit by means of engineering and work practice controls, as required by paragraph (f)(1) of this section, and by the use of respiratory protection where required or permitted under this section.
Respiratory protection and personal protective equipment -
Respirator program. The employer must implement a respiratory protection program in accordance with §1910.134(b) through (d) (except (d)(i)(iii)), and (f) through (m), which covers each employee required by this section to use a respirator.
Respirator selection. Employers must:
Emergency situations -
The plan shall include the elements prescribed in 29 CFR 1910.38 and 29 CFR 1910.39, "Emergency action plans" and "Fire prevention plans," respectively.
Alerting employees. Where there is the possibility of employee exposure to EtO due to an emergency, means shall be developed to alert potentially affected employees of such occurrences promptly. Affected employees shall be immediately evacuated from the area in the event that an emergency occurs.
Medical Surveillance -
Examination by a physician. The employer shall ensure that all medical examinations and procedures are performed by or under the supervision of a licensed physician, and are provided without cost to the employee, without loss of pay, and at a reasonable time and place.
Medical examinations and consultations -
Frequency. The employer shall make available medical examinations and consultations to each employee covered under paragraph (i)(1)(i) of this section on the following schedules:
Medical examinations made available pursuant to paragraphs (i)(2)(i)(A)-(D) of this section shall include:
Information provided to the physician. The employer shall provide the following information to the examining physician:
Physician's written opinion.
Communication of hazards -
Hazard communication - general.
Chemical manufacturers, importers, distributors and employers shall comply with all requirements of the Hazard Communication Standard (HCS) (§1910.1200) for EtO.
Employers shall include EtO in the hazard communication program established to comply with the HCS (§1910.1200). Employers shall 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 paragraph (j)(3) of this section.
Signs and labels -
The employer shall post and maintain legible signs demarcating regulated areas and entrances or access ways to regulated areas that bear the following legend:
MAY CAUSE CANCER
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(2)(i)(A) of this section:
CANCER HAZARD AND REPRODUCTIVE HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS AREA
CONTAINS ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD;
The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency.
Information and training.
The medical surveillance program required by paragraph (i) of this section with an explanation of the information in appendix C.
Objective data for exempted operations.
Name and exposure of the employees whose exposures are represented.
The name of the employee;
The employer, upon request, shall make any exemption and exposure records required by paragraphs (k) (1) and (2) of this section available for examination and copying to affected employees, former employees, designated representatives and the Assistant Secretary, in accordance with 29 CFR 1910.1020 (a) through (e) and (g) through (i).
Transfer of records. The employer shall comply with the requirements concerning transfer of records set forth in 29 CFR 1910.1020(h).
Observation of monitoring -
Employee observation. The employer shall provide affected employees or their designated representatives an opportunity to observe any monitoring of employee exposure to EtO conducted in accordance with paragraph (d) of this section.
Observation procedures. When observation of the monitoring of employee exposure to EtO requires entry into an area where the use of protective clothing or equipment is required, the observer shall be provided with and be required to use such clothing and equipment and shall comply with all other applicable safety and health procedures.
Appendices. The information contained in the appendices is not intended by itself to create any additional obligations not otherwise imposed or to detract from any existing obligation.
[61 FR 5507, Feb. 13, 1996; 63 FR 1152, Jan. 8, 1998; 67 FR 67965, Nov. 7, 2002; 70 FR 1143, Jan. 5, 2005; 71 FR 16672 and 16673, April 3, 2006; 71 FR 50190, August 24, 2006; 73 FR 75586, Dec. 12, 2008; 76 FR 33609, June 8, 2011; 77 FR 17783, March 26, 2012; 84 FR 21598, May 14, 2019]