Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(a)
Scope and Application.
(1) This section
applies to all occupational exposures to ethylene oxide (EtO) except as
provided in subsection (a)(2).
(2)
This section does not apply to the processing, use, or handling of products
made from or containing EtO where objective data demonstrate that the product
is not capable of releasing airborne EtO in concentrations at or above the
action level under conditions of processing, use, or handling that would
reasonably be expected to cause the greatest possible release.
(3) Where a product is exempted pursuant to
subsection (a)(2), the employer shall maintain a record of the objective data
supporting that exemption and the basis for the employer's reliance on the
data, as provided in subsection (k)(1).
(4) Sections
5221 and
5222 also apply where EtO is used
in walk-in chambers for fumigation or sterilization purposes.
(5) Every employer using EtO shall report
such use(s) to the Chief in accordance with subsection (m) except to the extent
that the use of EtO is exempt under the provisions of subsection
(a)(2).
(b) Definitions:
For the purpose of this section, the following definitions shall apply:
"Action Level." Employee exposure to airborne EtO at an
8-hour time-weighted average concentration of 0.5 part EtO per million parts of
air (0.5 ppm).
"Authorized Person." 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 subsection (3).
" Chief. " The chief administrative officer of the
Division of Occupational Safety and Health, P.O. Box 420603, San Francisco, CA
94142.
"Director." The Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and Human Services,
or designee.
"Emergency." 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." Exposure to airborne EtO without
regard to the employee's use of respiratory protective equipment.
"Ethylene Oxide" or "EtO." The three-membered ring
compound with the empirical chemical formula, C2H4O, and Chemical Abstracts
Service Register No. 75-21-8.
(c) Permissible Exposure Limit (PEL).
(1) Permissible Exposure Limit (PEL). The
employer shall ensure that no employee is exposed to an 8-hour time-weighted
average concentration of airborne EtO in excess of one (1) part EtO per million
parts of air (1 ppm).
(2) Short
Term Exposure Limit (STEL). The employer shall ensure that no employee is
exposed to a concentration of airborne 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.
(d) Exposure
Monitoring.
(1) General.
(A) Determinations of employee exposure shall
be made from breathing zone air samples that are representative of the 8-hour
time-weighted average exposure of each employee.
(B) Determinations of representative employee
exposure shall be based on one or more samples representing full-shift exposure
for each shift for each job classification in each work area.
(C) Where the employer can document that
exposure levels are equivalent for similar operations on different work shifts,
the employer need only determine representative employee exposure for such
operations during one shift.
(2) Initial Monitoring.
(A) Each employer who has a workplace or work
operation covered by this regulation, except as provided for in subsections
(a)(2) or (d)(2)(B), shall perform initial monitoring to determine accurately
the concentrations of airborne EtO to which employees may be exposed.
(B) Where the employer has monitored after
June 15, 1983 and the monitoring satisfies all other requirements of this
section, the employer may rely on such earlier monitoring results to satisfy
the requirements of subsection (d)(2)(A).
(3) Monitoring Frequency (Periodic
Monitoring).
(A) If the monitoring required by
subsection (d)(2) reveals employee exposure at or above the action level but
not above the permissible exposure limit, the employer shall repeat such
monitoring for each such employee at least every 6 months.
(B) If the monitoring required by subsection
(d)(2)(A) reveals employee exposure above the permissible exposure limit, the
employer shall repeat such monitoring for each such employee at least every 3
months.
(C) The employer may alter
the monitoring schedule from quarterly to semiannually for any employee for
whom two consecutive measurements taken at listed 7 days apart indicate that
the employee's exposure has decreased to or below the permissible exposure
limit.
(D) If the monitoring
required by subsection (d) (2) (A) reveals employee exposure above the STEL,
the employer shall repeat such monitoring for each such employee at least every
3 months, and more often as necessary to evaluate the employee's short term
exposures.
(4)
Termination of Monitoring.
(A) If the initial
monitoring required by subsection (d)(2)(A) reveals employee exposure to be
below the action level, the employer may discontinue the monitoring for those
employees whose exposures are represented by the initial monitoring.
(B) If the periodic monitoring required by
subsection (d)(3) reveals that employee exposures, as indicated by at least two
consecutive measurements taken at least 7 days apart, are below the action
level, the employer may discontinue the monitoring for those employees whose
exposures are represented by such monitoring.
(C) If the initial monitoring required by
subsection (d) (2) reveals employee exposure to be at or below the STEL, the
employer may discontinue short term exposure monitoring for those employees
whose exposures are represented by the initial monitoring.
(D) If the periodic monitoring required by
subsection (d) (3) (D) reveals that employee exposures, as indicated by at
least two consecutive measurements taken at least 7 days apart, are at or below
the STEL, the employer may discontinue short term exposure monitoring for those
employees whose exposures are represented by such
monitoring.
(5)
Additional Monitoring. Notwithstanding the provisions of subsection (d)(4), the
employer shall institute the exposure monitoring required under subsections
(d)(2)(A) and (d)(3) whenever there has been a change in the production,
process, control equipment, personnel or work practices that may result in new
or additional employee exposures or when the employer has any reason to suspect
that a change may result in new or additional exposures.
(6) Accuracy of Monitoring.
(A) Monitoring shall be accurate, to a
confidence level of 95 percent, to within plus or minus 25 percent for
concentrations of airborne EtO at the permissible exposure limit and to within
plus or minus 35 percent for concentrations of airborne EtO at the action
level.
(B) Monitoring shall be
accurate, to a confidence level of 95 percent, to within plus or minus 35
percent for concentrations of airborne EtO at the STEL.
(7) Employee Notification of Monitoring
Results.
(A) The employer shall, within 15
working days after the receipt of the results of any monitoring performed under
this regulation, notify the affected employee of these results in writing
either individually or by posting the results in an appropriate location that
is accessible to affected employees.
(B) The written notification required by
subsection (d)(7)(A) shall describe the corrective action being taken by the
employer to reduce employee exposure to or below the PEL or STEL wherever
monitoring results indicated that the PEL and/or STEL has been
exceeded.
(e)
Regulated Areas.
(1) The employer shall
establish a regulated area wherever employee exposures may exceed the PEL or
can reasonably be expected to exceed the STEL.
(2) Access to regulated areas shall be
limited to authorized persons.
(3)
Regulated areas shall be demarcated in any manner that minimizes the number of
employees within the regulated area.
(4) Regulated areas shall be posted in
accordance with subsection (j)(1).
(f) Methods of Compliance.
(1) Engineering Controls and Work Practices.
(A) The employer shall institute engineering
controls and work practices to reduce and maintain employee exposure to or
below the PEL except to the extent that such controls are not
feasible.
(B) Wherever the feasible
engineering controls and work practices that can be instituted are not
sufficient to reduce employee exposure to or below the PEL, the employer shall
use them to reduce employee exposure to the lowest levels achievable by these
controls and shall supplement them by the use of respiratory protection that
complies with the requirements of subsection (g).
NOTE: Engineering controls are generally infeasible for
the following operations: collection of quality assurance sampling from
sterilized materials; removal of biological indicators from sterilized
materials; loading and unloading of tank cars; changing of ethylene oxide tanks
on sterilizers; and vessel cleaning. For these operations, engineering controls
are required only where the Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor or the Chief demonstrate that such
controls are feasible.
(2) Compliance Program.
(A) Where the PEL is exceeded, the employer
shall establish and implement a written program to reduce employee exposure to
or below the PEL by means of engineering and work practice controls, as
required by subsection (f)(1), and by the use of respiratory protection where
required or permitted under this section.
(B) The compliance program shall include a
schedule for periodic leak detection surveys and, as specified in subsection
(h)(1), a written plan for emergency situations.
(C) Written plans for a program required in
subsection (f)(2) shall be developed and furnished upon request for examination
and copying to authorized representatives of the Chief, the Director, affected
employees and designated employee representatives. Such plans shall be reviewed
at least every 12 months, and shall be updated as necessary to reflect
significant changes in the status of the employer's compliance
program.
(D) The employer shall not
implement a schedule of employee rotation as a means of compliance with the PEL
or the STEL.
(g) Respiratory Protection and Personal
Protective Equipment.
(1) General. For
employees who are required to use respirators by this section, the employer
must provide respirators that comply with the requirements of this subsection.
Respirators must be used during:
(A) Periods
necessary to install or implement feasible engineering and work practice
controls;
(B) Work operations such
as maintenance and repair activities, vessel cleaning, or other activities for
which engineering and work practice controls are not feasible;
(C) Work operations for which feasible
engineering and work practice controls are not yet sufficient to reduce
exposure to or below the PEL; and
(D) Emergencies.
(2) Respirator program. The employer must
implement a respiratory protection program in accordance with section
5144(b) (except
(d)(1)(C)) through (m).
(3)
Respirator Selection.
(A) The employer shall
select, and provide to employees, the appropriate respirators specified in
Section 5144(d)(3)(A)1;
however, employers shall not select or use half masks of any type because EtO
may cause eye irritation or injury.
(B) Each air-purifying, full facepiece
respirator shall be equipped with a front- or back-mounted canister approved
for protection against ethylene oxide.
(C) For escape, the employer shall provide
employees with any respirator permitted for use under subsections (g)(3)(A) and
(B).
(4) Protective
Clothing and Equipment. Where eye or skin contact with liquid EtO or EtO
solutions may occur, the employer shall select and provide, at no cost to the
employee, appropriate protective clothing or other equipment in accordance with
Sections 3380,
3382,
3383, and
3384 to protect any area of the
body that may come in contact with liquid EtO or EtO in solution and shall
ensure that the employee wears the protective clothing and equipment
provided.
(h) Emergency
Situations.
(1) Written Plan.
(A) A written plan for emergency situations
shall be developed for each workplace where there is a possibility of an
emergency. Appropriate portions of the plan shall be implemented in the event
of an emergency.
(B) The plan shall
specifically provide that employees engaged in correcting emergency conditions
shall be equipped with respiratory protection as required by subsection (g)
until the emergency is abated.
(C)
The plan shall include the elements prescribed by Section
3220, Emergency Action Plan, and
Section 3221, Fire Prevention
Plan.
(2) Alerting
Employees. Where there is the possibility of employee exposure to EtO due to an
emergency, means shall be developed and provided to promptly alert potentially
affected employees upon such occurrences. Affected employees not engaged in
correcting the emergency conditions shall be immediately evacuated from the
area and shall not be permitted to return until the emergency is
abated.
(3) Reporting of
Emergencies. Emergencies shall be reported to the Chief in accordance with
subsection (m).
(i)
Medical Surveillance.
(1) General.
(A) The employer shall institute a medical
surveillance program for all employees who are or may be exposed to EtO at or
above the action level, without regard to the use of respirators, for at least
30 days a year.
(B) The employer
shall make available medical examinations and consultations to all employees
who have been exposed to EtO in an emergency situation.
(C) 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
employee loss of pay, and at a reasonable time and place.
(2) Frequency of Medical Examinations and
Consultations. The employer shall make medical examinations and consultations
available to each employee covered under subsections (i)(1)(A) and (B) on the
following schedules:
(A) Prior to assignment
of the employee to an area where exposure may be at or above the action level
for at least 30 days a year.
(B) At
least annually for each employee exposed at or above the action level for at
least 30 days in the preceding year.
(C) At termination of employment or upon
reassignment to an area where employee exposure is not at or above the action
level for at least 30 days a year.
(D) As medically appropriate for any employee
exposed during an emergency.
(E) As
soon as possible following notification of the employer by an employee either
(1) that the employee has developed signs or symptoms indicating possible
overexposure to EtO, or (2) that the employee desires medical advice concerning
the effects of current or past exposure to EtO on the employee's ability to
produce a healthy child.
(F) If the
examining physician determines that any of the examinations should be provided
more frequently than specified, the employer shall provide such examination to
affected employees at the frequencies recommended by the
physician.
(3) Content of
Medical Examinations and Consultations.
(A)
Medical examinations made available pursuant to subsection (i)(2)(A)-(D) shall
include:
1. A medical and work history with
special emphasis directed to symptoms related to the pulmonary, hematologic,
neurologic, and reproductive systems and to the eyes and skin;
2. A physical examination with particular
emphasis given to the pulmonary, hematologic, neurologic, and reproductive
systems and to the eyes and skin;
3. A complete blood count to include at least
a white cell count (including differential cell count) and red cell count and
hematocrit and hemoglobin determinations; and
4. Any laboratory or other test which the
examining physician deems necessary by sound medical
practice.
(B) The content
of medical examinations or consultations made available pursuant to subsection
(i)(2)(E) shall be determined by the examining physician and shall include
pregnancy testing or laboratory evaluation of fertility if requested by the
employee and deemed appropriate by the physician.
(4) Information Provided to the Physician.
The employer shall provide the following information to the examining
physician:
(A) A copy of this standard and
Appendices A, B and C;
(B) A
description of the affected employee's duties as they relate to the employee's
exposure;
(C) The employee's
representative exposure level or anticipated exposure level;
(D) A description of any personal protective
and respiratory equipment used or to be used; and
(E) Information from previous medical
examinations of the affected employee that is not otherwise available to the
examining physician.
(5)
Physician's Written Opinion.
(A) The employer
shall obtain a written opinion from the examining physician. This written
opinion shall contain the results of the medical examination and shall include:
1. The physician's opinion as to whether the
employee has any detected medical conditions that would place the employee at
an increased risk of material health impairment from exposure to EtO;
2. Any recommended limitations on the
employee or upon the use of personal protective equipment such as clothing or
respirators; and
3. A statement
that the employee has been informed by the physician of the results of the
medical examination and of any medical conditions resulting from EtO exposure
that require further explanation or treatment.
(B) The employer shall instruct the physician
not to reveal in the written opinion given to the employer specific findings or
diagnoses unrelated to occupational exposure to EtO.
(C) The employer shall provide a copy of the
physician's written opinion to the affected employee within 15 days from its
receipt.
(j)
Communication of Hazards.
(1) Hazard
communication--general.
(A) Chemical
manufacturers, importers, distributors and employers shall comply with all
requirements of the Hazard Communication Standard (HCS) (Section
5194) for EtO.
(B) 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.
(C) Employers shall
include EtO in the hazard communication program established to comply with the
HCS (Section
5194). 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
subsection (j)(3) of this section.
(2) Signs and Labels.
(A) Signs.
1. The employer shall post and maintain
legible signs demarcating regulated areas and entrances or access ways to
regulated areas that bear the following legend:
DANGER
ETHYLENE OXIDE
MAY CAUSE CANCER
MAY DAMAGE FERTILITY OR THE UNBORN
CHILD
RESPIRATORY PROTECTION AND PROTECTIVE
CLOTHING
MAY BE REQUIRED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
2. Prior to June 1, 2016, employers may use
the following legend in lieu of that specified in subsection (j)(2)(A)1. of
this section:
DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE
HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY
BE
REQUIRED TO BE WORN IN THIS
AREA
(B)
Labels.
1. The employer shall ensure that
precautionary labels are affixed to all containers the contents of which are
capable of causing employee exposure at or above the action level, or the
contents of which may reasonably be foreseen to cause employee exposure above
the excursion limit and that the labels remain affixed when the containers
leave the workplace. For the purposes of this subsection (j)(2)(B), reaction
vessels, storage tanks and pipes or piping systems are not considered to be
containers.
2. Prior to June 1,
2015, employers may include the following information on containers of EtO in
lieu of the labeling requirements in subsection (j)(1)(A) of this section:
a. DANGER
CONTAINS ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD;
b. A warning statement against breathing
airborne concentrations of EtO.
(C) 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.
(3) Information
and Training.
(A) The employer shall provide
employees who are potentially exposed to EtO at or above the action level with
information and training on EtO at the time of initial assignment and at least
annually thereafter.
(B) Employees
shall be informed of the following:
1. The
requirements of this regulation with an explanation of its contents, including
Appendices A and B;
2. All
operations in their work area where EtO is present;
3. The location and availability of this
regulation within the workplace; and
4. The medical surveillance program required
by subsection (i) with an explanation of the information in Appendix
C.
(C) Employee training
shall include at least:
1. Methods and
observations that may be used to detect the presence or release of EtO in the
work area (such as monitoring conducted by the employer, continuous monitoring
devices, etc.);
2. The physical and
health hazards of EtO;
3. The
measures employees can take to protect themselves from hazards associated with
EtO exposure, including specific procedures the employer has implemented to
protect employees from exposure to EtO, such as work practices, emergency
procedures, and personal protective equipment to be used; and
4. The details of the hazard communication
program developed by the employer in accordance with Section
5194, including an explanation of
the labeling system and how employees can obtain and use the appropriate hazard
information.
(k) Recordkeeping.
(1) Objective Data For Exempted Operations.
(A) Where the processing, use, or handling of
products made from or containing EtO are exempted from other requirements of
this regulation under subsection (a)(2), or where objective data such as
earlier monitoring have been relied on in lieu of initial monitoring under
subsection (d)(2)(B), the employer shall establish and maintain an accurate
record of objective data reasonably relied upon in support of the
exemption.
(B) This record shall
include at least the following information:
1.
The product qualifying for exemption;
2. The source of the objective
data;
3. The testing protocol,
results of testing, and/or analysis of the material for the release of
EtO;
4. A description of the
operation exempted and how the data support the exemption; and
5. Other data relevant to the operations,
materials, processing, or employee exposures covered by the
exemption.
(C) The
employer shall maintain this record for the duration of the employer's reliance
upon such objective data.
(2) Exposure Measurements.
(A) The employer shall keep an accurate
record of all measurements taken to monitor employee exposure to EtO as
prescribed in subsection (d).
(B)
This record shall include at least the following information:
1. The date of measurement;
2. The operation involving exposure to EtO
which is being monitored;
3.
Sampling and analytical methods used and evidence of their accuracy;
4. Number, duration, and results of samples
taken;
5. Type of protective
devices worn, if any; and
6. Name,
social security number and exposure of the employees whose exposures are
represented.
(C) The
employer shall maintain this record for at least thirty (30)
years.
(3) Medical
Surveillance.
(A) The employer shall
establish and maintain an accurate record for each employee subject to medical
surveillance as prescribed by subsection (i)(1).
(B) The record shall include at least the
following information:
1. The name and social
security number of the employee;
2.
Physicians' written opinions;
3.
Any employee medical complaints related to exposure to EtO; and
4. A copy of the information provided to the
physician as required by subsection (i)(4).
(C) The employer shall ensure that this
record is maintained for the duration of employment plus thirty (30)
years.
(4) Availability.
(A) The employer, upon written request, shall
make all records required to be maintained by this section available to
authorized representatives of the Chief and the Director for examination and
copying.
(B) The employer, upon
request, shall make any exemption and exposure records required by subsections
(k)(1) and (k)(2) of this section available for examination and copying to
affected employees, former employees, designated representatives, and
authorized representatives of the Chief, in accordance with Section
3204(a)-(e) and
(g)-(i).
(C) The employer, upon request, shall make
employee medical records required by subsection (k)(3) available for
examination and copying to the subject employee, anyone having the specific
written consent of the subject employee, and authorized representatives of the
Chief, in accordance with Section
3204.
(5) Transfer of Records.
(A) The employer shall comply with the
requirements concerning transfer of records set forth in Section
3204(h).
(B) Whenever the employer ceases to do
business and there is no successor employer to receive and retain the records
for the prescribed period, the employer shall notify the Director in writing at
least 90 days prior to their disposal and shall transmit them to the Director
if requested to do so within the 90-day period.
(l) Observation of Monitoring.
(1) 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 subsection (d).
(2)
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 be required to comply with all of the
applicable safety and health procedures.
(m) Notification of Use and Emergencies. See
section 5203.
(n) Appendices. The information contained in
the appendices is not intended by itself to create any additional obligations
nor otherwise imposed by this section or to detract from any existing
obligation.
1. New
section filed 1-16-85; effective thirtieth day thereafter (Register 85, No.
3).
2. Change without regulatory effect of NOTE filed 2-14-86;
effective thirtieth day thereafter (Register 86, No. 7).
3.
Amendment of subsection (j)(1)(b)1. filed 8-4-86; effective thirtieth day
thereafter (Register 86, No. 32).
4. Amendment of subsections (a),
(c), (d), (e), (f), (g) and (j), repealer of subsection (n) and relettering of
former subsection (o) to subsection (n) filed 1-12-90; operative 2-11-90
(Register 90, No. 5).
5. Change withour regulatory effect amending
definition of Chief in subsection (b) filed 3-4-92 pursuant to section
100, title 1, California Code of
Regulations (Register 92, No. 19).
6. Editorial correction of
printing error in Appendix A subsection (d)[ii] and NOTE (Register 92, No.
19).
7. Amendment of former subsections (g)(1)-(g)(3)(B) including
subsection renumbering and relettering resulting in newly designated
subsections (g)(1)-(g)(3), and amendment of appendix A, subsection IV. filed
8-25-98; operative 11-23-98 (Register 98, No. 35).
8. Editorial
correction moving NOTE and HISTORIES 1-7 from following Appendix D to preceding
Appendix A (Register 99, No. 28).
9. Amendment of subsection (m),
repealer of subsections (m)(1)-(4) and amendment of NOTE filed 7-6-99;
operative 8-5-99 (Register 99, No. 28).
10. Amendment of subsection
(g)(2) filed 7-31-2003; operative 8-30-2003 (Register 2003, No.
31).
11. Amendment of subsection (g)(3)(A) and new subsections
(g)(3)(B)-(C) filed 3-6-2007; operative 3-6-2007. Submitted to OAL for printing
only pursuant to Labor Code section
142.3(a)(3)
(Register 2007, No. 10).
12. Amendment of subsection (j) and
subsections therein filed 5-6-2013; operative 5-6-2013 pursuant to Labor Code
section
142.3(a)(4)(C).
Submitted to OAL for printing only pursuant to Labor Code section
142.3(a)(4)
(Register 2013, No. 19).
13. Amendment of subsection (j) and
subsections therein refiled 11-6-2013; operative 11-6-2013 pursuant to Labor
Code section
142.3(a)(4)(C).
Submitted to OAL for printing only pursuant to Labor Code section
142.3(a)(4)
(Register 2013, No. 45).
14. Repealer of 11-6-2013 order by
operation of law 5-6-2014 pursuant to Labor Code 142.3 (Register 2014, No.
19).
15. Amendment of subsection (j) and subsections therein filed
5-5-2014; operative 5-6-2014 pursuant to Government Code section
11343.4(b)(3)
(Register 2014, No. 19).
Note: Authority cited: Sections
142.3,
9020,
9030 and
9040, Labor
Code. Reference: Sections
142.3,
9004(d),
9009,
9020,
9030,
9031 and
9040, Labor
Code.
