Ethylene Oxide (29 CFR 1910.1047)

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Occupational Safety and Health Admin., Labor
the first (larger) section is transferred to a 2ml vial. The separating section of foam is removed and discarded; the section is transferred to another capped vial. These two sections are analyzed separately.
5.4.2 Desorption of samples. Prior to analysis, 1.0 ml of methanol is pipetted into each
sample container. Desorption should be done
for 30 minutes in an ultrasonic bath. The
sample vials are recapped as soon as the solvent is added.
5.4.3 GC conditions. The typical operating
conditions for the gas chromatograph are:
1. 30 ml/min (60 psig) helium carrier gas
flow.
2. 3.0 ml/min (30 psig) hydrogen gas flow to
detector.
3. 50 ml/min (60 psig) air flow to detector.
4. 200 °C injector temperature.
5. 200 °C dejector temperature.
6. 100 °C column temperature.
5.4.4 Injection. Solvent flush technique or
equivalent.
5.4.5 Measurement of area. The area of the
sample peak is measured by an electronic
integator or some other suitable form of area
measurement, and preliminary results are
read from a standard curve prepared as discussed below.
5.5 Determination of desorption efficiency.
5.5.1 Importance of determination. The
desorption efficiency of a particular compound can vary from one laboratory to another and also from one batch of charcoal to
another. Thus, it is necessary to determine,
at least once, the percentage of the specific
compound that is removed in the desorption
process, provided the same batch of charcoal
is used.
5.5.2 Procedure for determining desorption
efficiency. The reference portion of the charcoal tube is removed. To the remaining portion, amounts representing 0.5X, 1X, and 2X
(X represents TLV) based on a 20 l air sample
are injected onto several tubes at each level.
Dilutions of acrylonitrile with methanol are
made to allow injection of measurable quantities. These tubes are then allowed to
equilibrate at least overnight. Following
equilibration they are analyzed following the
same procedure as the samples A curve of
the desorption efficiency amt recovered/amt
added is plotted versus amount of analyte
found. This curve is used to correct for adsorption losses.
6. Calibration and standards.
A series of standards, varying in concentration over the range of interest, is prepared and analyzed under the same GC conditions and during the same time period as the
unknown samples. Curves are prepared by
plotting concentration versus peak area.
NOTE: Since no internal standard is used in
the method, standard solutions must be analyzed at the same time that the sample analysis is done. This will minimize the effect of
known day-to-day variations and variations

§ 1910.1047

during the same day of the NPD response.
Multiple injections are necessary.
7. Calculations.
Read the weight, corresponding to each
peak area from the standard curve, correct
for the blank, correct for the desorption efficiency, and make necessary air volume corrections.
8. Reference. NIOSH Method S–156.
[43 FR 45809, Oct. 3, 1978, as amended at 45 FR
35283, May 23, 1980; 54 FR 24334, June 7, 1989;
58 FR 35310, June 30, 1993; 61 FR 5508, Feb. 13,
1996; 63 FR 1291, Jan. 8, 1998; 63 FR 20099, Apr.
23, 1998; 70 FR 1142, Jan. 5, 2005; 71 FR 16672,
16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006;
73 FR 75586, Dec. 12, 2008]

§ 1910.1047 Ethylene oxide.
(a) Scope and application. (1) This section applies to all occupational exposures to ethylene oxide (EtO), Chemical Abstracts Service Registry No. 75–
21–8, except as provided in paragraph
(a)(2) of this section.
(2) 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.
(3) Where products containing EtO
are exempted under paragraph (a)(2) of
this section, the employer shall maintain records of the objective data supporting that exemption and the basis
for the employer’s reliance on the data,
as provided in paragraph (k)(1) of this
section.
(b) 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

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

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.
(c) Permissible exposure limits—(1) 8hour 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).
(2) 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.
(d) Exposure monitoring—(1) General.
(i) Determinations of employee exposure shall be made from breathing zone
air samples that are representative of
the 8-hour TWA and 15-minute shortterm exposures of each employee.
(ii) Representative 8-hour TWA employee exposure shall be determined on
the basis of one or more samples representing full-shift exposure for each
shift for each job classification in each
work area. Representative 15-minute
short-term employee exposures shall be
determined on the basis of one or more
samples representing 15-minute exposures associated with operations that
are most likely to produce exposures
above the excursion limit for each shift

for each job classification in each work
area.
(iii) Where the employer can document that exposure levels are equivalent for similar operations in different
work shifts, the employer need only determine representative employee exposure for that operation during one
shift.
(2) Initial monitoring. (i) Each employer who has a workplace or work
operation covered by this standard, except as provided for in paragraph (a)(2)
or (d)(2)(ii) of this section, shall perform initial monitoring to determine
accurately the airborne concentrations
of EtO to which employees may be exposed.
(ii) 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 paragraph
(d)(2)(i) of this section.
(iii) 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.
(3) Monitoring frequency (periodic monitoring). (i) If the monitoring required
by paragraph (d)(2) of this section reveals employee exposure at or above
the action level but at or below the 8hour TWA, the employer shall repeat
such monitoring for each such employee at least every 6 months.
(ii) If the monitoring required by
paragraph (d)(2)(i) of this section reveals employee exposure above the 8hour TWA, the employer shall repeat
such monitoring for each such employee at least every 3 months.
(iii) The employer may alter the
monitoring schedule from quarterly to
semiannually for any employee for
whom two consecutive measurements
taken at least 7 days apart indicate
that the employee’s exposure has decreased to or below the 8-hour TWA.
(iv) If the monitoring required by
paragraph (d)(2)(i) of this section reveals employee exposure above the 15
minute excursion limit, the employer
shall repeat such monitoring for each

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such employee at least every 3 months,
and more often as necessary to evaluate exposure the employee’s short-term
exposures.
(4) Termination of monitoring. (i) If the
initial monitoring required by paragraph (d)(2)(i) of this section reveals
employee exposure to be below the action level, the employer may discontinue TWA monitoring for those
employees whose exposures are represented by the initial monitoring.
(ii) 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 below the action level,
the employer may discontinue TWA
monitoring for those employees whose
exposures are represented by such monitoring.
(iii) 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.
(iv) 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.
(5) 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.
(6) Accuracy of monitoring. (i) Monitoring shall be accurate, to a confidence level of 95 percent, to within
plus or minus 25 percent for airborne
concentrations of EtO at the 1 ppm
TWA and to within plus or minus 35

§ 1910.1047

percent for airborne concentrations of
EtO at the action level of 0.5 ppm.
(ii) Monitoring shall be accurate, to a
confidence level of 95 percent, to within plus or minus 35 percent for airborne
concentrations of EtO at the excursion
limit.
(7) Employee notification of monitoring
results. (i) The employer must, within
15 working days after the receipt of the
results of any monitoring performed
under this section, notify each affected
employee of these results either individually in writing or by posting the
results in an appropriate location that
is accessible to employees.
(ii) The written notification required
by paragraph (d)(7)(i) of this section
shall contain the corrective action
being taken by the employer to reduce
employee exposure to or below the
TWA and/or excursion limit, wherever
monitoring results indicated that the
TWA and/or excursion limit has been
exceeded.
(e) Regulated areas. (1) 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.
(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.
(f) Methods of compliance—(1) Engineering controls and work practices. (i)
The employer shall institute engineering controls and work practices to reduce and maintain employee exposure
to or below the TWA and to or below
the excursion limit, except to the extent that such controls are not feasible.
(ii) Wherever the feasible engineering
controls and work practices that can
be instituted are not sufficient to reduce employee exposure to or below the
TWA and to or below the excursion
limit, 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 paragraph (g)
of this section.

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

(iii) 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 demonstrates that such controls are feasible.
(2) Compliance program. (i) 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.
(ii) The compliance program shall include a schedule for periodic leak detection surveys and a written plan for
emergency situations, as specified in
paragraph (h)(i) of this section.
(iii) Written plans for a program required in paragraph (f)(2) shall be developed and furnished upon request for
examination and copying to the Assistant Secretary, 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.
(iv) The employer shall not implement a schedule of employee rotation
as a means of compliance with the
TWA or excursion limit.
(g) Respiratory protection and personal
protective equipment—(1) General. For
employees who use respirators required
by this section, the employer must provide each employee an appropriate respirator that complies with the requirements of this paragraph. Respirators
must be used during:
(i) Periods necessary to install or implement feasible engineering and workpractice controls.
(ii) Work operations, such as maintenance and repair activities and vessel
cleaning, for which engineering and
work-practice controls are not feasible.

(iii) Work operations for which feasible engineering and work-practice
controls are not yet sufficient to reduce employee exposure to or below the
TWA.
(iv) Emergencies.
(2) 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.
(3) Respirator selection. Employers
must:
(i) Select, and provide to employees,
the appropriate respirators specified in
paragraph (d)(3)(i)(A) of 29 CFR
1910.134; however, employers must not
select or use half masks of any type because EtO may cause eye irritation or
injury.
(ii) Equip each air-purifying, full
facepiece respirator with a front-or
back-mounted canister approved for
protection against ethylene oxide.
(iii) For escape, provide employees
with any respirator permitted for use
under paragraphs (g)(3)(i) and (ii) of
this standard.
(4) Protective clothing and equipment.
When employees could have eye or skin
contact with EtO or EtO solutions, the
employer must select and provide, at
no cost to the employee, appropriate
protective clothing or other equipment
in accordance with 29 CFR 1910.132 and
1910.133 to protect any area of the employee’s body that may come in contact with the EtO or EtO solution, and
must ensure that the employee wears
the protective clothing and equipment
provided.
(h) Emergency situations—(1) Written
plan. (i) 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.
(ii) The plan shall specifically provide that employees engaged in correcting emergency conditions shall be
equipped with respiratory protection as
required by paragraph (g) of this section until the emergency is abated.
(iii) The plan shall include the elements prescribed in 29 CFR 1910.38 and
29 CFR 1910.39, ‘‘Emergency action

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plans’’ and ‘‘Fire prevention plans,’’ respectively.
(2) 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.
(i) Medical Surveillance—(1) General—
(i) Employees covered. (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.
(ii) 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.
(2) Medical examinations and consultations—(i) 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:
(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 each employee
exposed at or above the action level for
at least 30 days in the past year.
(C) At termination of employment or
reassignment to an area where exposure to EtO 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, upon notification 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

§ 1910.1047

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 examinations to affected employees
at
the
frequencies
recommended by the physician.
(ii) Content. (A) Medical examinations made available pursuant to paragraphs (i)(2)(i)(A)–(D) of this section
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), red cell count,
hematocrit, and hemoglobin.
(4) Any laboratory or other test
which the examining physician deems
necessary by sound medical practice.
(B) The content of medical examinations or consultation made available
pursuant to paragraph (i)(2)(i)(E) of
this section 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.
(3) Information provided to the physician. The employer shall provide the
following information to the examining physician:
(i) A copy of this standard and Appendices A, B, and C.
(ii) A description of the affected employee’s duties as they relate to the
employee’s exposure.
(iii) The employee’s representative
exposure level or anticipated exposure
level.
(iv) A description of any personal
protective and respiratory equipment
used or to be used.
(v) Information from previous medical examinations of the affected employee that is not otherwise available
to the examining physician.

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29 CFR Ch. XVII (7–1–09 Edition)

(4) Physician’s written opinion. (i) 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:
(A) 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;
(B) Any recommended limitations on
the employee or upon the use of personal protective equipment such as
clothing or respirators; and
(C) 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.
(ii) 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.
(iii) 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 EtO hazards to
employees—(1) Signs and labels. (i) The
employer shall post and maintain legible signs demarcating regulated areas
and entrances or accessways to regulated areas that bear the following legend:

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DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE
HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE
CLOTHING MAY BE REQUIRED
TO BE WORN IN THIS AREA

(ii) The employer shall ensure that
precautionary labels are affixed to all
containers of EtO whose contents are
capable of causing employee exposure
at or above the action level or whose
contents may reasonably be foreseen to
cause employee exposure above the excursion limit, and that the labels remain affixed when the containers of
EtO leave the workplace. For the purpose of this paragraph, reaction vessels, storage tanks, and pipes or piping
systems are not considered to be con-

tainers. The labels shall comply with
the requirements of 29 CFR 1910.1200(f)
of OSHA’s Hazard Communication
standard, and shall include the following legend:
(A) DANGER
CONTAINS ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE
HAZARD;

and
(B) A warning statement against
breathing airborne concentrations of
EtO.
(iii) 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.
(2) Material safety data sheets. Employers who are manufacturers or importers of EtO shall comply with the
requirements regarding development of
material safety data sheets as specified
in 29 CFR 1910.1200(g) of OSHA’s Hazard
Communication standard.
(3) Information and training. (i) The
employer shall provide employees who
are potentially exposed to EtO at or
above the action level or above the excursion limit with information and
training on EtO at the time of initial
assignment and at least annually
thereafter.
(ii) Employees shall be informed of
the following:
(A) The requirements of this section
with an explanation of its contents, including Appendices A and B;
(B) Any operations in their work area
where EtO is present;
(C) The location and availability of
the written EtO final rule; and
(D) The medical surveillance program required by paragraph (i) of this
section with an explanation of the information in Appendix C.
(iii) Employee training shall include
at least:
(A) 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.);

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Occupational Safety and Health Admin., Labor
(B) The physical and health hazards
of EtO;
(C) 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
(D) The details of the hazard communication program developed by the employer, 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. (i) Where the
processing, use, or handling of products
made from or containing EtO are exempted from other requirements of this
section under paragraph (a)(2) of this
section, or where objective data have
been relied on in lieu of initial monitoring under paragraph (d)(2)(ii) of this
section, the employer shall establish
and maintain an accurate record of objective data reasonably relied upon in
support of the exemption.
(ii) This record shall include at least
the following information:
(A) The product qualifying for exemption;
(B) The source of the objective data;
(C) The testing protocol, results of
testing, and/or analysis of the material
for the release of EtO;
(D) A description of the operation exempted and how the data support the
exemption; and
(E) Other data relevant to the operations, materials, processing, or employee exposures covered by the exemption.
(iii) The employer shall maintain
this record for the duration of the employer’s reliance upon such objective
data.
(2) Exposure measurements. (i) The employer shall keep an accurate record of
all measurements taken to monitor
employee exposure to EtO as prescribed
in paragraph (d) of this section.
(ii) This record shall include at least
the following information:
(A) The date of measurement;
(B) The operation involving exposure
to EtO which is being monitored;

§ 1910.1047

(C) Sampling and analytical methods
used and evidence of their accuracy;
(D) Number, duration, and results of
samples taken;
(E) Type of protective devices worn,
if any; and
(F) Name, social security number and
exposure of the employees whose exposures are represented.
(iii) The employer shall maintain
this record for at least thirty (30)
years, in accordance with 29 CFR
1910.1020.
(3) Medical surveillance. (i) The employer shall establish and maintain an
accurate record for each employee subject to medical surveillance by paragraph (i)(1)(i) of this section, in accordance with 29 CFR 1910.1020.
(ii) The record shall include at least
the following information:
(A) The name and social security
number of the employee;
(B) Physicians’ written opinions;
(C) Any employee medical complaints related to exposure to EtO; and
(D) A copy of the information provided to the physician as required by
paragraph (i)(3) of this section.
(iii) The employer shall ensure that
this record is maintained for the duration of employment plus thirty (30)
years, in accordance with 29 CFR
1910.1020.
(4) Availability. (i) The employer,
upon written request, shall make all
records required to be maintained by
this section available to the Assistant
Secretary and the Director for examination and copying.
(ii) 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).
(iii) The employer, upon request,
shall make employee medical records
required by paragraph (k)(3) of this section available for examination and
copying to the subject employee, anyone having the specific written consent
of the subject employee, and the Assistant Secretary, in accordance with
29 CFR 1910.1020.

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29 CFR Ch. XVII (7–1–09 Edition)

(5) Transfer of records. (i) The employer shall comply with the requirements concerning transfer of records
set forth in 29 CFR 1910.1020(h).
(ii) 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 at
least 90 days prior to disposal and
transmit them to the Director.
(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 paragraph (d) of this
section.
(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 comply with all
other applicable safety and health procedures.
(m) [Reserved]
(n) 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.
APPENDIX A TO § 1910.1047—SUBSTANCE SAFETY DATA SHEET FOR ETHYLENE OXIDE (NONMANDATORY)

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I.

SUBSTANCE IDENTIFICATION

A. Substance: Ethylene oxide (C2 H4 O).
B. Synonyms: dihydrooxirene, dimethylene
oxide, EO, 1,2-epoxyethane, EtO, ETO,
oxacyclopropane, oxane, oxidoethane, alpha/
beta-oxidoethane, oxiran, oxirane.
C. Ethylene oxide can be found as a liquid
or vapor.
D. EtO is used in the manufacture of ethylene glycol, surfactants, ethanolamines, glycol ethers, and other organic chemicals. EtO
is also used as a sterilant and fumigant.
E. Appearance and odor: Colorless liquid
below 10.7 °C (51.3 °F) or colorless gas with
ether-like odor detected at approximately
700 parts EtO per million parts of air (700
ppm).
F. Permissible Exposure: Exposure may
not exceed 1 part EtO per million parts of air
averaged over the 8-hour workday.

II.

HEALTH HAZARD DATA

A. Ethylene oxide can cause bodily harm if
you inhale the vapor, if it comes into contact with your eyes or skin, or if you swallow it.
B. Effects of overexposure:
1. Ethylene oxide in liquid form can cause
eye irritation and injury to the cornea, frostbite, and severe irritation and blistering of
the skin upon prolonged or confined contact.
Ingestion of EtO can cause gastric irritation
and liver injury. Acute effects from inhalation of EtO vapors include respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and
cyaonosis (blue or purple coloring of skin).
Exposure has also been associated with the
occurrence of cancer, reproductive effects,
mutagenic changes, neurotoxicity, and sensitization.
1. EtO has been shown to cause cancer in
laboratory animals and has been associated
with higher incidences of cancer in humans.
Adverse reproductive effects and chromosome damage may also occur from EtO
exposure.
a. Reporting signs and symptoms: You
should inform your employer if you develop
any signs or symptoms and suspect that they
are caused by exposure to EtO.
III.

EMERGENCY FIRST AID PROCEDURES

A. Eye exposure: If EtO gets into your
eyes, wash your eyes immediately with large
amounts of water, lifting the lower and
upper eyelids. Get medical attention immediately. Contact lenses should not be worn
when working with this chemical.
B. Skin exposure: If EtO gets on your skin,
immediately wash the contaminated skin
with water. If EtO soaks through your clothing, especially your shoes, remove the clothing immediately and wash the skin with
water using an emergency deluge shower.
Get medical attention immediately. Thoroughly wash contaminated clothing before
reusing. Contaminated leather shoes or other
leather articles should not be reused and
should be discarded.
C. Inhalation: If large amounts of EtO are
inhaled, the exposed person must be moved
to fresh air at once. If breathing has stopped,
perform
cardiopulmonary
resuscitation.
Keep the affected person warm and at rest.
Get medical attention immediately.
D. Swallowing: When EtO has been swallowed, give the person large quantities of
water immediately. After the water has been
swallowed, try to get the person to vomit by
having him or her touch the back of the
throat with his or her finger. Do not make
an unconscious person vomit. Get medical
attention immediately.
E. Rescue: Move the affected person from
the hazardous exposure. If the exposed person has been overcome, attempt rescue only

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Occupational Safety and Health Admin., Labor
after notifying at least one other person of
the emergency and putting into effect established emergency procedures. Do not become
a casualty yourself. Understand your emergency rescue procedures and know the location of the emergency equipment before the
need arises.

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IV.

RESPIRATORS AND PROTECTIVE CLOTHING

A. Respirators. You may be required to
wear a respirator for nonroutine activities,
in emergencies, while your employer is in
the process of reducing EtO exposures
through engineering controls, and in areas
where engineering controls are not feasible.
As of the effective date of this standard, only
air-supplied, positive-pressure, full-facepiece
respirators are approved for protection
against EtO. If air-purifying respirators are
worn in the future, they must have a label
issued by the National Institute for Occupational Safety and Health under the provisions of 42 CFR part 84 stating that the respirators have been approved for use with
ethylene oxide. For effective protection, respirators must fit your face and head snugly.
Respirators must not be loosened or removed
in work situations where their use is required.
EtO does not have a detectable odor except
at levels well above the permissible exposure
limits. If you can smell EtO while wearing a
respirator, proceed immediately to fresh air.
If you experience difficulty breathing while
wearing a respirator, tell your employer.
B. Protective clothing: You may be required to wear impermeable clothing, gloves,
a face shield, or other appropriate protective
clothing to prevent skin contact with liquid
EtO or EtO-containing solutions. Where protective clothing is required, your employer
must provide clean garments to you as necessary to assure that the clothing protects
you adequately.
Replace or repair protective clothing that
has become torn or otherwise damaged.
EtO must never be allowed to remain on
the skin. Clothing and shoes which are not
impermeable to EtO should not be allowed to
become contaminated with EtO, and if they
do, the clothing should be promptly removed
and decontaminated. Contaminated leather
shoes should be discarded. Once EtO penetrates shoes or other leather articles, they
should not be worn again.
C. Eye protection: You must wear
splashproof safety goggles in areas where liquid EtO or EtO-containing solutions may
contact your eyes. In addition, contact
lenses should not be worn in areas where eye
contact with EtO can occur.

V.

§ 1910.1047

PRECAUTIONS FOR SAFE USE, HANDLING,
AND STORAGE

A. EtO is a flammable liquid, and its vapors can easily form explosive mixtures in
air.
B. EtO must be stored in tighly closed containers in a cool, well-ventilated area, away
from heat, sparks, flames, strong oxidizers,
alkalines, and acids, strong bases, acetylideforming metals such as cooper, silver, mercury and their alloys.
C. Sources of ignition such as smoking material, open flames and some electrical devices are prohibited wherever EtO is handled,
used, or stored in a manner that could create
a potential fire or explosion hazard.
D. You should use non-sparking tools when
opening or closing metal containers of EtO,
and containers must be bonded and grounded
in the rare instances in which liquid EtO is
poured or transferred.
E. Impermeable clothing wet with liquid
EtO or EtO-containing solutions may be easily ignited. If your are wearing impermeable
clothing and are splashed with liquid EtO or
EtO-containing solution, you should immediately remove the clothing while under an
emergency deluge shower.
F. If your skin comes into contact with liquid EtO or EtO-containing solutions, you
should immediately remove the EtO using an
emergency deluge shower.
G. You should not keep food, beverages, or
smoking materials in regulated areas where
employee exposures are above the permissible exposure limits.
H. Fire extinguishers and emergency deluge showers for quick drenching should be
readily available, and you should know
where they are and how to operate them.
I. Ask your supervisor where EtO is used in
your work area and for any additional plant
safety and health rules.
VI.

ACCESS TO INFORMATION

A. Each year, your employer is required to
inform you of the information contained in
this standard and appendices for EtO. In addition, your employer must instruct you in
the proper work practices for using EtO
emergency procedures, and the correct use of
protective equipment.
B. Your employer is required to determine
whether you are being exposed to EtO. You
or your representative has the right to observe employee measurements and to record
the results obtained. Your employer is required to inform you of your exposure. If
your employer determine that you are being
overexposed, he or she is required to inform
you of the actions which are being taken to
reduce your exposure to within permissible
exposure limits.
C. Your employer is required to keep
records of your exposures and medical examinations. These exposure records must be

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

kept by the employer for at least thirty (30)
years. Medical records must be kept for the
period of your employment plus thirty (30)
years.
D. Your employer is required to release
your exposure and medical records to your
physician or designated representative upon
your written request.
VII.

STERILANT USE OF ETO IN HOSPITALS AND
HEALTH CARE FACILITIES

This section of Appendix A, for informational purposes, sets forth EPA’s recommendations for modifications in workplace design and practice in hospitals and
health care facilities for which the Environmental Protection Agency has registered
EtO for uses as a sterilant or fumigant under
the Federal Insecticide, Funigicide, and
Rodenticide Act, 7 U.S.C. 136 et seq. These
new recommendations, published in the FEDERAL REGISTER by EPA at 49 FR 15268, as
modified in today’s REGISTER, are intended
to help reduce the exposure of hospital and
health care workers to EtO to 1 ppm. EPA’s
recommended workplace design and workplace practice are as follows:

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1. Workplace Design
a. Installation of gas line hand valves. Hand
valves must be installed on the gas supply
line at the connection to the supply cylinders to minimize leakage during cylinder
change.
b. Installation of capture boxes. Sterilizer
operations result in a gas/water discharge at
the completion of the process. This discharge
is routinely piped to a floor drain which is
generally located in an equipment or an adjacent room. When the floor drain is not in
the same room as the sterilizer and workers
are not normally present, all that is necessary is that the room be well ventilated.
The installation of a ‘‘capture box’’ will be
required for those work place layouts where
the floor drain is located in the same room
as the sterilizer or in a room where workers
are normally present. A ‘‘capture box’’ is a
piece of equipment that totally encloses the
floor drain where the discharge from the
sterilizer is pumped. The ‘‘capture box’’ is to
be vented directly to a non-recirculating or
dedicated ventilation system. Sufficient air
intake should be allowed at the bottom of
the box to handle the volume of air that is
ventilated from the top of the box. The
‘‘capture box’’ can be made of metal, plastic,
wood or other equivalent material. The box
is intended to reduce levels of EtO discharged into the work room atmosphere. The
use of a ‘‘capture box’’ is not required if: (1)
The vacuum pump discharge floor drain is located in a well ventilated equipment or other
room where workers are not normally
present or (2) the water sealed vacuum pump

discharges directly to a closed sealed sewer
line (check local plumbing codes).
If it is impractical to install a vented
‘‘capture box’’ and a well ventilated equipment or other room is not feasible, a box
that can be sealed over the floor drain may
be used if: (1) The floor drain is located in a
room where workers are not normally
present and EtO cannot leak into an occupied area, and (2) the sterilizer in use is less
than 12 cubic feet in capacity (check local
plumbing codes).
c. Ventilation of aeration units i. Existing
aeration units. Existing units must be vented
to a non-recirculating or dedicated system or
vented to an equipment or other room where
workers are not normally present and which
is well ventilated. Aerator units must be positioned as close as possible to the sterilizer
to minimize the exposure from the off-gassing of sterilized items.
ii. Installation of new aerator units (where
none exist). New aerator units must be vented
as described above for existing aerators.
Aerators must be in place by July 1, 1986.
d. Ventilation during cylinder change. Workers may be exposed to short but relatively
high levels of EtO during the change of gas
cylinders. To reduce exposure from this
route, users must select one of three alternatives designed to draw off gas that may be
released when the line from the sterilizer to
the cylinder is disconnected:
i. Location of cylinders in a well ventilated
equipment room or other room where workers are not normally present.
ii. Installation of a flexible hose (at least 4″
in diameter) to a non-recirculating or dedicated ventilation system and located in the
area of cylinder change in such a way that
the hose can be positioned at the point where
the sterilizer gas line is disconnected from
the cylinder.
iii. Installation of a hood that is part of a
non-recirculating or dedicated system and
positioned no more than one foot above the
point where the change of cylinders takes
place.
e. Ventilation of sterilizer door area. One of
the major sources of exposure to EtO occurs
when the sterilizer door is opened following
the completion of the sterilization process.
In order to reduce this avenue of exposure, a
hood or metal canopy closed on each end
must be installed over the sterilizer door.
The hood or metal canopy must be connected
to a non-recirculating or dedicated ventilation system or one that exhausts gases to a
well ventilated equipment or other room
where workers are not normally present. A
hood or canopy over the sterilizer door is required for use even with those sterilizers
that have a purge cycle and must be in place
by July 1, 1986.
f. Ventilation of sterilizer relief valve. Sterilizers are typically equipped with a safety relief device to release gas in case of increased

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Occupational Safety and Health Admin., Labor
pressure in the sterilizer. Generally, such relief devices are used on pressure vessels. Although these pressure relief devices are rarely opened for hospital and health care sterilizers, it is suggested that they be designed
to exhaust vapor from the sterilizer by one
of the following methods:
i. Through a pipe connected to the outlet
of the relief valve ventilated directly outdoors at a point high enough to be away from
passers by, and not near any windows that
open, or near any air conditioning or ventilation air intakes.
ii. Through a connection to an existing or
new non-recirculating or dedicated ventilation system.
iii. Through a connection to a well ventilated equipment or other room where workers are not normally present.
g. Ventilation systems. Each hospital and
health care facility affected by this notice
that uses EtO for the sterilization of equipment and supplies must have a ventilation
system which enables compliance with the
requirements of section (b) through (f) in the
manner described in these sections and within the timeframes allowed. Thus, each affected hospital and health care facility must
have or install a non-recirculating or dedicated ventilation equipment or other room
where workers are not normally present in
which to vent EtO.
h. Installation of alarm systems. An audible
and visual indicator alarm system must be
installed to alert personnel of ventilation
system failures, i.e., when the ventilation
fan motor is not working.

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2. Workplace Practices
All the workplace practices discussed in
this unit must be permanently posted near
the door of each sterilizer prior to use by any
operator.
a. Changing of supply line filters. Filters in
the sterilizer liquid line must be changed
when necessary, by the following procedure:
i. Close the cylinder valve and the hose
valve.
ii. Disconnect the cylinder hose (piping)
from the cylinder.
iii. Open the hose valve and bleed slowly
into a proper ventilating system at or near
the in-use supply cylinders.
iv. Vacate the area until the line is empty.
v. Change the filter.
vi. Reconnect the lines and reverse the
value position.
vii. Check hoses, filters, and valves for
leaks with a fluorocarbon leak detector (for
those sterilizers using the 88 percent
chlorofluorocarbon, 12 percent ethylene
oxide mixture (12/88)).
b. Restricted access area. i. Areas involving
use of EtO must be designated as restricted
access areas. They must be identified with
signs or floor marks near the sterilizer door,

§ 1910.1047

aerator, vacuum pump floor drain discharge,
and in-use cylinder storage.
ii. All personnel must be excluded from the
restricted area when certain operations are
in progress, such as discharging a vacuum
pump, emptying a sterilizer liquid line, or
venting a non-purge sterilizer with the door
ajar or other operations where EtO might be
released directly into the face of workers.
c. Door opening procedures. i. Sterilizers with
purge cycles. A load treated in a sterilizer
equipped with a purge cycle should be removed immediately upon completion of the
cycle (provided no time is lost opening the
door after cycle is completed). If this is not
done, the purge cycle should be repeated before opening door.
ii. Sterilizers without purge cycles. For a load
treated in a sterilizer not equipped with a
purge cycle, the sterilizer door must be ajar
6″ for 15 minutes, and then fully opened for
at least another 15 minutes before removing
the treated load. The length of time of the
second period should be established by peak
monitoring for one hour after the two 15minute periods suggested. If the level is
above 10 ppm time-weighted average for 8
hours, more time should be added to the second waiting period (door wide open). However, in no case may the second period be
shortened to less than 15 minutes.
d. Chamber unloading procedures. i. Procedures for unloading the chamber must include the use of baskets or rolling carts, or
baskets and rolling tables to transfer treated
loads quickly, thus avoiding excessive contact with treated articles, and reducing the
duration of exposures.
ii. If rolling carts are used, they should be
pulled not pushed by the sterilizer operators
to avoid offgassing exposure.
e. Maintenance. A written log should be instituted and maintained documenting the
date of each leak detection and any maintenance procedures undertaken. This is a suggested use practice and is not required.
i. Leak detection. Sterilizer door gaskets,
cylinder and vacuum piping, hoses, filters,
and valves must be checked for leaks under
full pressure with a Fluorocarbon leak detector (for 12/88 systems only) every two weeks
by maintenance personnel. Also, the cylinder
piping connections must be checked after
changing cylinders. Particular attention in
leak detection should be given to the automatic solenoid valves that control the flow
of EtO to the sterilizer. Specifically, a check
should be made at the EtO gasline entrance
port to the sterilizer, while the sterilizer
door is open and the solenoid valves are in a
closed position.
ii. Maintenance procedures. Sterilizer/
areator door gaskets, valves, and fittings
must be replaced when necessary as determined by maintenance personnel in their biweekly checks; in addition, visual inspection
of the door gaskets for cracks, debris, and

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

other foreign substances should be conducted
daily by the operator.
APPENDIX B TO § 1910.1047—SUBSTANCE TECHNICAL GUIDELINES FOR ETHYLENE OXIDE
(NON-MANDATORY)
I.

PHYSICAL AND CHEMICAL DATA

A. Substance identification:
1. Synonyms: dihydrooxirene, dimethylene
oxide, EO, 1,2-epoxyethane, EtO ETO
oxacyclopropane, oxane, oxidoethane, alpha/
beta-oxidoethane, oxiran, oxirane.
2. Formula: (C2 H4 O).
3. Molecular weight: 44.06
B. Physical data:
1. Boiling point (760 mm Hg): 10.70 °C (51.3
°F);
2. Specific gravity (water = 1): 0.87 (at 20 °C
or 68 °F)
3. Vapor density (air = 1): 1.49;
4. Vapor pressure (at 20 °C); 1,095 mm Hg;
5. Solubility in water: complete;
6. Appearance and odor: colorless liquid;
gas at temperature above 10.7 °F or 51.3 °C
with ether-like odor above 700 ppm.

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II.

FIRE, EXPLOSION, AND REACTIVITY HAZARD
DATA

A. Fire:
1. Flash point: less than O °F (open cup);
2. Stability: decomposes violently at temperatures above 800 °F;
3. Flammable limits in air, percent by volume: Lower: 3, Upper: 100;
4. Extinguishing media: Carbon dioxide for
small fires, polymer or alcohol foams for
large fires;
5. Special fire fighting procedures: Dilution
of ethylene oxide with 23 volumes of water
renders it non-flammable;
6. Unusual fire and explosion hazards: Vapors of EtO will burn without the presence of
air or other oxidizers. EtO vapors are heavier
than air and may travel along the ground
and be ignited by open flames or sparks at
locations remote from the site at which EtO
is being used.
7. For purposes of compliance with the requirements of 29 CFR 1910.106, EtO is classified as a flammable gas. For example, 7,500
ppm, approximately one-fourth of the lower
flammable limit, would be considered to pose
a potential fire and explosion hazard.
8. For purposes of compliance with 29 CFR
1910.155, EtO is classified as a Class B fire
hazard.
9. For purpose of compliance with 29 CFR
1919.307, locations classified as hazardous due
to the presence of EtO shall be Class I.
B. Reactivity:
1. Conditions contributing to instability:
EtO will polymerize violently if contaminated with aqueous alkalies, amines, mineral acids, metal chlorides, or metal oxides.
Violent decomposition will also occur at
temperatures above 800 °F;

2. Incompatabilities: Alkalines and acids;
3. Hazardous decomposition products: Carbon monoxide and carbon dioxide.
III.

SPILL, LEAK, AND DISPOSAL PROCEDURES

A. If EtO is spilled or leaked, the following
steps should be taken:
1. Remove all ignition sources.
2. The area should be evacuated at once
and re-entered only after the area has been
thoroughly ventilated and washed down with
water.
B. Persons not wearing appropriate protective equipment should be restricted from
areas of spills or leaks until cleanup has
been completed.
C. Waste disposal methods: Waste material
should be disposed of in a manner that is not
hazardous to employees or to the general
population. In selecting the method of waste
disposal, applicable local, State, and Federal
regulations should be consulted.
IV.

MONITORING AND MEASUREMENT
PROCEDURES

A. Exposure above the Permissible Exposure Limit:
1. Eight-hour exposure evaluation: Measurements taken for the purpose of determining employee exposure under this section
are best taken with consecutive samples covering the full shift. Air samples should be
taken in the employee’s breathing zone (air
that would most nearly represent that inhaled by the employee.)
2. Monitoring techniques: The sampling
and analysis under this section may be performed by collection of the EtO vapor on
charcoal adsorption tubes or other composition adsorption tubes, with subsequent
chemical analysis. Sampling and analysis
may also be performed by instruments such
as real-time continuous monitoring systems,
portable direct reading instruments, or passive dosimeters as long as measurements
taken using these methods accurately evaluate the concentration of EtO in employees’
breathing zones.
Appendix D describes the validated method
of sampling and analysis which has been
tested by OSHA for use with EtO. Other
available methods are also described in Appendix D. The employer has the obligation of
selecting a monitoring method which meets
the accuracy and precision requirements of
the standard under his unique field conditions. The standard requires that the method
of monitoring should be accurate, to a 95 percent confidence level, to plus or minus 25
percent for concentrations of EtO at 1 ppm,
and to plus or minus 35 percent for concentrations at 0.5 ppm. In addition to the
method described in Appendix D, there are
numerous other methods available for monitoring for EtO in the workplace. Details on
these other methods have been submitted by

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Occupational Safety and Health Admin., Labor
various companies to the rulemaking record,
and are available at the OSHA Docket Office.
B. Since many of the duties relating to employee exposure are dependent on the results
of measurement procedures, employers
should assure that the evaluation of employee exposures is performed by a technically qualified person.

§ 1910.1047

chemicals, and use as a sterilant in the hospital, health product and spice industries.
APPENDIX C TO § 1910.1047—MEDICAL SURVEILLANCE GUIDELINES FOR ETHYLENE OXIDE
(NON-MANDATORY)
I. ROUTE OF ENTRY

Inhalation.
V.

PROTECTIVE CLOTHING AND EQUIPMENT

Employees should be provided with and be
required to wear appropriate protective
clothing wherever there is significant potential for skin contact with liquid EtO or EtOcontaining solutions. Protective clothing
shall include impermeable coveralls or similar full-body work clothing, gloves, and head
coverings, as appropriate to protect areas of
the body which may come in contact with
liquid EtO or EtO-containing solutions.
Employers should ascertain that the protective garments are impermeable to EtO.
Permeable clothing, including items made of
rubber, and leather shoes should not be allowed to become contaminated with liquid
EtO. If permeable clothing does become contaminated, it should be immediately removed, while the employer is under an emergency deluge shower. If leather footwear or
other leather garments become wet from EtO
they should be discarded and not be worn
again, because leather absorbs EtO and holds
it against the skin.
Any protective clothing that has been
damaged or is otherwise found to be defective should be repaired or replaced. Clean
protective clothing should be provided to the
employee as necessary to assure employee
protection. Whenever impermeable clothing
becomes wet with liquid EtO, it should be
washed down with water before being removed by the employee. Employees are also
required to wear splash-proof safety goggles
where there is any possibility of EtO contacting the eyes.
VI.

MISCELLANEOUS PRECAUTIONS

A. Store EtO in tightly closed containers
in a cool, well-ventilated area and take all
necessary precautions to avoid any explosion
hazard.
B. Non-sparking tools must be used to open
and close metal containers. These containers
must be effectively grounded and bonded.
C. Do not incinerate EtO cartridges, tanks
or other containers.
D. Employers should advise employees of
all areas and operations where exposure to
EtO occur.

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VII.

COMMON OPERATIONS

Common operations
EtO is likely to occur
Manufacture
of
ethanolamines, glycol

in which exposure to
include the following:
EtO,
surfactants,
ethers, and specialty

II. TOXICOLOGY

Clinical evidence of adverse effects associated with the exposure to EtO is present in
the form of increased incidence of cancer in
laboratory animals (leukemia, stomach,
brain), mutation in offspring in animals, and
resorptions and spontaneous abortions in
animals and human populations respectively. Findings in humans and experimental
animals exposed to airborne concentrations
of EtO also indicate damage to the genetic
material (DNA). These include hemoglobin
alkylation, unsecheduled DNA synthesis, sister chromatid exchange chromosomal aberration, and functional sperm abnormalities.
Ethylene oxide in liquid form can cause
eye irritation and injury to the cornea, frostbite, severe irritation, and blistering of the
skin upon prolonged or confined contact. Ingestion of EtO can cause gastric irritation
and liver injury. Other effects from inhalation of EtO vapors include respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, dyspnea and cyanosis.
III. SIGNS AND SYMPTOMS OF ACUTE
OVEREXPOSURE

The early effects of acute overexposure to
EtO are nausea and vomiting, headache, and
irritation of the eyes and respiratory passages. The patient may notice a ‘‘peculiar
taste’’ in the mouth. Delayed effects can include pulmonary edema, drowsiness, weakness, and incoordination. Studies suggest
that blood cell changes, an increase in chromosomal aberrations, and spontaneous abortion may also be causally related to acute
overexposure to EtO.
Skin contact with liquid or gaseous EtO
causes characteristic burns and possibly
even an allergic-type sensitization. The
edema and erythema occurring from skin
contact with EtO progress to vesiculation
with a tendency to coalesce into blebs with
desquamation. Healing occurs within three
weeks, but there may be a residual brown
pigmentation. A 40–80% solution is extremely dangerous, causing extensive blistering after only brief contact. Pure liquid
EtO causes frostbite because of rapid evaporation. In contrast, the eye is relatively insensitive to EtO, but there may be some irritation of the cornea.
Most reported acute effects of occupational
exposure to EtO are due to contact with EtO
in liquid phase. The liquid readily penetrates

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

rubber and leather, and will produce blistering if clothing or footwear contaminated
with EtO are not removed.

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IV. SURVEILLANCE AND PREVENTIVE
CONSIDERATIONS

As noted above, exposure to EtO has been
linked to an increased risk of cancer and reproductive effects including decreased male
fertility, fetotoxicity, and spontaneous abortion. EtO workers are more likely to have
chromosomal damage than similar groups
not exposed to EtO. At the present, limited
studies of chronic effects in humans resulting from exposure to EtO suggest a causal
association with leukemia. Animal studies
indicate leukemia and cancers at other sites
(brain, stomach) as well. The physician
should be aware of the findings of these studies in evaluating the health of employees exposed to EtO.
Adequate screening tests to determine an
employee’s potential for developing serious
chronic diseases, such as cancer, from exposure to EtO do not presently exist. Laboratory tests may, however, give evidence to
suggest that an employee is potentially overexposed to EtO. It is important for the physician to become familiar with the operating
conditions in which exposure to EtO is likely
to occur. The physician also must become familiar with the signs and symptoms that indicate a worker is receiving otherwise unrecognized and unacceptable exposure to EtO.
These elements are especially important in
evaluating the medical and work histories
and in conducting the physical exam. When
an unacceptable exposure in an active employee is identified by the physician, measures taken by the employer to lower exposure should also lower the risk of serious
long-term consequences.
The employer is required to institute a
medical surveillance program for all employees who are or will be exposed to EtO at or
above the action level (0.5 ppm) for at least
30 days per year, without regard to respirator use. All examinations and procedures
must be performed by or under the supervision of a licensed physician at a reasonable
time and place for the employee and at no
cost to the employee.
Although broad latitude in prescribing specific tests to be included in the medical surveillance program is extended to the examining physician, OSHA requires inclusion of
the following elements in the routine examination:
(i) Medical and work histories with special
emphasis directed to symptoms related to
the pulmonary, hematologic, neurologic, and
reproductive systems and to the eyes and
skin.
(ii) Physical examination with particular
emphasis given to the pulmonary, hematologic, neurologic, and reproductive systems
and to the eyes and skin.

(iii) Complete blood count to include at
least a white cell count (including differential cell count), red cell count, hematocrit,
and hemoglobin.
(iv) Any laboratory or other test which the
examining physician deems necessary by
sound medical practice.
If requested by the employee, the medical
examinations shall include pregnancy testing or laboratory evaluation of fertility as
deemed appropriate by the physician.
In certain cases, to provide sound medical
advice to the employer and the employee,
the physician must evaluate situations not
directly related to EtO. For example, employees with skin diseases may be unable to
tolerate wearing protective clothing. In addition those with chronic respiratory diseases may not tolerate the wearing of negative pressure (air purifying) respirators. Additional tests and procedures that will help
the physician determine which employees
are medically unable to wear such respirators should include: An evaluation of
cardiovascular function, a baseline chest xray to be repeated at five year intervals, and
a pulmonary function test to be repeated
every three years. The pulmonary function
test should include measurement of the employee’s forced vital capacity (FVC), forced
expiratory volume at one second (FEV1), as
well as calculation of the ratios of FEV1 to
FVC, and measured FVC and measured FEV1
to expected values corrected for variation
due to age, sex, race, and height.
The employer is required to make the prescribed tests available at least annually to
employees who are or will be exposed at or
above the action level, for 30 or more days
per year; more often than specified if recommended by the examining physician; and
upon the employee’s termination of employment or reassignment to another work area.
While little is known about the long term
consequences of high short-term exposures,
it appears prudent to monitor such affected
employees closely in light of existing health
data. The employer shall provide physician
recommended examinations to any employee
exposed to EtO in emergency conditions.
Likewise, the employer shall make available
medical consultations including physician
recommended exams to employees who believe they are suffering signs or symptoms of
exposure to EtO.
The employer is required to provide the
physician with the following informatin: a
copy of this standard and its appendices; a
description of the affected employee’s duties
as they relate to the employee exposure
level; and information from the employee’s
previous medical examinations which is not
readily available to the examining physician. Making this information available to
the physician will aid in the evaluation of
the employee’s health in relation to assigned

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Occupational Safety and Health Admin., Labor
duties and fitness to wear personal protective equipment, when required.
The employer is required to obtain a written opinion from the examining physician
containing the results of the medical examinations; the physician’s opinion as to whether the employee has any detected medical
conditions which would place the employee
at increased risk of material impairment of
his or her health from exposure to EtO; any
recommended restrictions upon the employee’s exposure to EtO, or upon the use of protective clothing or equipment such as respirators; and a statement that the employee
has been informed by the physician of the results of the medical examination and of any
medical conditions which require further explanation or treatment. This written opinion
must not reveal specific findings or diagnoses unrelated to occupational exposure to
EtO, and a copy of the opinion must be provided to the affected employee.
The purpose in requiring the examining
physician to supply the employer with a
written opinion is to provide the employer
with a medical basis to aid in the determination of initial placement of employees and to
assess the employee’s ability to use protective clothing and equipment.

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APPENDIX D TO § 1910.1047—SAMPLING AND ANALYTICAL METHODS FOR ETHYLENE OXIDE
(NON-MANDATORY)
A number of methods are available for
monitoring employee exposures to EtO. Most
of these involve the use of charcoal tubes
and sampling pumps, followed by analysis of
the samples by gas chromatograph. The essential differences between the charcoal tube
methods include, among others, the use of
different desorbing solvents, the use of different lots of charcoal, and the use of different equipment for analysis of the samples.
Besides charcoal, methods using passive
dosimeters, gas sampling bags, impingers,
and detector tubes have been utilized for determination of EtO exposure. In addition,
there are several commercially available
portable gas analyzers and monitoring units.
This appendix contains details for the
method which has been tested at the OSHA
Analytical Laboratory in Salt Lake City. Inclusion of this method in the appendix does
not mean that this method is the only one
which will be satisfactory. Copies of descriptions of other methods available are available in the rulemaking record, and may be
obtained from the OSHA Docket Office.
These include the Union Carbide, Dow Chemical, 3M, and DuPont methods, as well as
NIOSH Method S–286. These methods are
briefly described at the end of this appendix.
Employers who note problems with sample
breakthrough using the OSHA or other charcoal methods should try larger charcoal
tubes. Tubes of larger capacity are available.
In addition, lower flow rates and shorter

§ 1910.1047

sampling times should be beneficial in minimizing breakthrough problems. Whatever
method the employer chooses, he must assure himself of the method’s accuracy and
precision under the unique conditions
present in his workplace.
ETHYLENE OXIDE
Method No.: 30.
Matrix: Air.
Target Concentration: 1.0 ppm (1.8 mg/m3).
Procedure: Samples are collected on two
charcoal tubes in series and desorbed with
1% CS2 in benzene. The samples are
derivatized with HBr and treated with sodium carbonate. Analysis is done by gas
chromatography with an electron capture
detector.
Recommended Air Volume and Sampling
Rate: 1 liter and 0.05 Lpm.
Detection Limit of the Overall Procedure:
13.3 ppb (0.024 mg/m3) (Based on 1.0 liter air
sample).
Reliable Quantitation Limit: 52.2 ppb (0.094
mg/m3) (Based on 1.0 liter air sample).
Standard Error of Estimate: 6.59% (See
Backup Section 4.6).
Special Requirements: Samples must be
analyzed within 15 days of sampling date.
Status of Method: The sampling and analytical method has been subjected to the established evaluation procedures of the Organic Method Evaluations Branch.
Date: August 1981.
Chemist: Wayne D. Potter.
ORGANIC SOLVENTS BRANCH, OSHA ANALYTICAL LABORATORY, SALT LAKE CITY, UTAH
1. General Discussion.
1.1 Background.
1.1.1 History of Procedure.
Ethylene oxide samples analyzed at the
OSHA Laboratory have normally been collected on activated charcoal and desorbed
with carbon disulfide. The analysis is performed with a gas chromatograph equipped
with a FID (Flame ionization detector) as described in NIOSH Method S286 (Ref. 5.1). This
method is based on a PEL of 50 ppm and has
a detection limit of about 1 ppm.
Recent studies have prompted the need for
a method to analyze and detect ethylene
oxide at very low concentrations.
Several attempts were made to form an ultraviolet (UV) sensitive derivative with
ethylene oxide for analysis with HPLC.
Among those tested that gave no detectable
product were: p-anisidine, methylimidazole,
aniline, and 2,3,6-trichlorobenzoic acid. Each
was
tested
with
catalysts
such
as
triethylamine, aluminum chloride, methylene chloride and sulfuric acid but no detectable derivative was produced.
The next derivatization attempt was to
react ethylene oxide with HBr to form 2bromoethanol. This reaction was successful.

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§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

An ECD (electron capture detector) gave a
very good response for 2-bromoethanol due
to the presence of bromine. The use of carbon disulfide as the desorbing solvent gave
too large a response and masked the 2bromoethanol. Several other solvents were
tested for both their response on the ECD
and their ability to desorb ethylene oxide
from the charcoal. Among those tested were
toluene, xylene, ethyl benzene, hexane,
cyclohexane and benzene. Benzene was the
only solvent tested that gave a suitable response on the ECD and a high desorption. It
was found that the desorption efficiency was
improved by using 1% CS2 with the benzene.
The carbon disulfide did not significantly
improve the recovery with the other solvents. SKC Lot 120 was used in all tests done
with activated charcoal.
1.1.2 Physical Properties (Ref. 5.2–5.4).
Synonyms: Oxirane; dimethylene oxide,
1,2-epoxy-ethane; oxane; C2 H4 O; ETO;
Molecular Weight: 44.06
Boiling Point: 10.7 °C (51.3°)
Melting Point: ¥111 °C
Description: Colorless, flammable gas
Vapor Pressure: 1095 mm. at 20 °C
Odor: Ether-like odor
Lower Explosive Limits: 3.0% (by volume)
Flash Point (TOC): Below 0 °F
Molecular Structure: CH2—CH2
1.2 Limit Defining Parameters.
1.2.1 Detection Limit of the Analytical
Procedure.
The detection limit of the analytical procedure is 12.0 picograms of ethylene oxide per
injection. This is the amount of analyte
which will give a peak whose height is five
times the height of the baseline noise. (See
Backup Data Section 4.1).
1.2.2 Detection Limit of the Overall Procedure.
The detection limit of the overall procedure is 24.0 ng of ethylene oxide per sample.
This is the amount of analyte spiked on
the sampling device which allows recovery of
an amount of analyte equivalent to the detection limit of the analytical procedure.
(See Backup Data Section 4.2).
1.2.3 Reliable Quantitation Limit.
The reliable quantitation limit is 94.0
nanograms of ethylene oxide per sample.
This is the smallest amount of analyte which
can be quantitated within the requirements
of 75% recovery and 95% confidence limits.
(See Backup Data Section 4.2).
It must be recognized that the reliable
quantitation limit and detection limits reported in the method are based upon optimization of the instrument for the smallest
possible amount of analyte. When the target
concentration of an analyte is exceptionally
higher than these limits, they may not be attainable at the routine operating parameters. In this case, the limits reported on
analysis reports will be based on the oper-

ating parameters used during the analysis of
the samples.
1.2.4 Sensitivity.
The sensitivity of the analytical procedure
over a concentration range representing 0.5
to 2 times the target concentration based on
the recommended air volume is 34105 area
units per μg/mL. The sensitivity is determined by the slope of the calibration curve
(See Backup Data Section 4.3).
The sensitivity will vary somewhat with
the particular instrument used in the analysis.
1.2.5 Recovery.
The recovery of analyte from the collection medium must be 75% or greater. The average recovery from spiked samples over the
range of 0.5 to 2 times the target concentration is 88.0% (See Backup Section 4.4). At
lower concentrations the recovery appears to
be non-linear.
1.2.6 Precision (Analytical Method Only).
The pooled coefficient of variation obtained from replicate determination of analytical standards at 0.5X, 1X and 2X the target concentration is 0.036 (See Backup Data
Section 4.5).
1.2.7 Precision (Overall Procedure).
The overall procedure must provide results
at the target concentration that are 25% of
better at the 95% confidence level. The precision at the 95% confidence level for the 15
day storage test is plus or minus 12.9% (See
Backup Data Section 4.6).
This includes an additional plus or minus
5% for sampling error.
1.3 Advantages.
1.3.1 The sampling procedure is convenient.
1.3.2 The analytical procedure is very sensitive and reproducible.
1.3.3 Reanalysis of samples is possible.
1.3.4 Samples are stable for at least 15
days at room temperature.
1.3.5 Interferences are reduced by the
longer GC retention time of the new derivative.
1.4 Disadvantages.
1.4.1 Two tubes in series must be used because of possible breakthrough and migration.
1.4.2 The precision of the sampling rate
may be limited by the reproducibility of the
pressure drop across the tubes. The pumps
are usually calibrated for one tube only.
1.4.3 The use of benzene as the desorption
solvent increases the hazards of analysis because of the potential carcinogenic effects of
benzene.
1.4.4 After repeated injections there can
be a buildup of residue formed on the electron capture detector which decreases sensitivity.
1.4.5 Recovery from the charcoal tubes appears to be nonlinear at low concentrations.
2. Sampling Procedure.
2.1 Apparatus.

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Occupational Safety and Health Admin., Labor
2.1.1 A calibrated personal sampling pump
whose flow can be determined within plus or
minus 5% of the recommended flow.
2.1.2 SKC Lot 120 Charcoal tubes: glass
tube with both ends flame sealed, 7 cm long
with a 6 mm O.D. and a 4-mm I.D., containing 2 sections of coconut shell charcoal
separated by a 2-mm portion of urethane
foam. The adsorbing section contains 100 mg
of charcoal, the backup section 50 mg. A 3mm portion of urethane foam is placed between the outlet end of the tube and the
backup section. A plug of silylated glass
wool is placed in front of the adsorbing section.
2.2 Reagents.
2.2.1 None required.
2.3 Sampling Technique.
2.3.1 Immediately before sampling, break
the ends of the charcoal tubes. All tubes
must be from the same lot.
2.3.2 Connect two tubes in series to the
sampling pump with a short section of flexible tubing. A minimum amount of tubing is
used to connect the two sampling tubes together. The tube closer to the pump is used
as a backup. This tube should be identified
as the backup tube.
2.3.3 The tubes should be placed in a
vertical position during sampling to minimize channeling.
2.3.4 Air being sampled should not pass
through any hose or tubing before entering
the charcoal tubes.
2.3.5 Seal the charcoal tubes with plastic
caps immediately after sampling. Also, seal
each sample with OSHA seals lengthwise.
2.3.6 With each batch of samples, submit
at least one blank tube from the same lot
used for samples. This tube should be subjected to exactly the same handling as the
samples (break, seal, transport) except that
no air is drawn through it.
2.3.7 Transport the samples (and corresponding paperwork) to the lab for analysis.
2.3.8 If bulk samples are submitted for
analysis, they shoud be transported in glass
containers with Teflon-lined caps. These
samples must be mailed separately from the
container used for the charcoal tubes.
2.4 Breakthrough.
2.4.1 The breakthrough (5% breakthrough)
volume for a 3.0 mg/m ethylene oxide sample
stream at approximately 85% relative humidity, 22 °C and 633 mm is 2.6 liters sampled
at 0.05 liters per minute. This is equivalent
to 7.8 μg of ethylene oxide. Upon saturation
of the tube it appeared that the water may
be displacing ethylene oxide during sampling.
2.5 Desorption Efficiency.
2.5.1 The desorption efficiency, from liquid injection onto charcoal tubes, averaged
88.0% from 0.5 to 2.0 × the target concentration for a 1.0 liter air sample. At lower
ranges it appears that the desorption effi-

§ 1910.1047

ciency is non-linear (See Backup Data Section 4.2).
2.5.2 The desorption efficiency may vary
from one laboratory to another and also
from one lot of charcoal to another. Thus, it
is necessary to determine the desorption efficiency for a particular lot of charcoal.
2.6 Recommended Air Volume and Sampling Rate.
2.6.1 The recommended air volume is 1.0
liter.
2.6.2 The recommended maximum sampling rate is 0.05 Lpm.
2.7 Interferences.
2.7.1 Ethylene glycol and Freon 12 at target concentration levels did not interfere
with the collection of ethylene oxide.
2.7.2 Suspected interferences should be
listed on the sample data sheets.
2.7.3 The relative humidity may affect the
sampling procedure.
2.8 Safety Precautions.
2.8.1 Attach the sampling equipment to
the employee so that it does not interfere
with work performance.
2.8.2 Wear safety glasses when breaking
the ends of the sampling tubes.
2.8.3 If possible, place the sampling tubes
in a holder so the sharp end is not exposed
while sampling.
3. Analytical Method.
3.1 Apparatus.
3.1.1 Gas chromatograph equipped with a
linearized electron capture detector.
3.1.2 GC column capable of separating the
derivative
of
ethylene
oxide
(2bromoethanol) from any interferences and
the 1% CS2 in benzene solvent. The column
used for validation studies was: 10 ft × 1⁄8 inch
stainless steel 20% SP–2100, .1% Carbowax
1500 on 100/120 Supelcoport.
3.1.3 An electronic integrator or some
other suitable method of measuring peak
areas.
3.1.4 Two milliliter vials with Teflonlined caps.
3.1.5 Gas tight syringe—500 μL or other
convenient sizes for preparing standards.
3.1.6 Microliter syringes—10 μL or other
convenient sizes for diluting standards and 1
μL for sample injections.
3.1.7 Pipets for dispensing the 1% CS2 in
benzene solvent. The Glenco 1 mL dispenser
is adequate and convenient.
3.1.8 Volumetric flasks—5 mL and other
convenient sizes for preparing standards.
3.1.9 Disposable Pasteur pipets.
3.2 Reagents.
3.2.1 Benzene, reagent grade.
3.2.2 Carbon Disulfide, reagent grade.
3.2.3 Ethylene oxide, 99.7% pure.
3.2.4 Hydrobromic Acid, 48% reagent
grade.
3.2.5 Sodium Carbonate, anhydrous, reagent grade.
3.2.6 Desorbing reagent, 99% Benzene/1%
CS2.

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29 CFR Ch. XVII (7–1–09 Edition)
3.7.1 The concentration in μg/mL for a
sample is determined by comparing the area
of a particular sample to the calibration
curve, which has been prepared from analytical standards.
3.7.2 The amount of analyte in each sample is corrected for desorption efficiency by
use of a desorption curve.
3.7.3 Analytical results (A) from the two
tubes that compose a particular air sample
are added together.
3.7.4 The concentration for a sample is
calculated by the following equation:

ETO, mg/m 3 =

AXB
C

where:
A=μg/mL
B=desorption volume in milliliters
C=air volume in liters.
3.7.5 To convert mg/m3 to parts per million (ppm) the following relationship is used:

ETO, ppm =

mg/m 3 × 24.45
44.05

where:
mg/m3=results from 3.7.4
24.45=molar volume at 25 °C and 760mm Hg
44.05=molecular weight of ETO.
3.8 Safety Precautions
3.8.1 Ethylene oxide and benzene are potential carcinogens and care must be exercised when working with these compounds.
3.8.2 All work done with the solvents
(preparation of standards, desorption of samples, etc.) should be done in a hood.
3.8.3 Avoid any skin contact with all of
the solvents.
3.8.4 Wear safety glasses at all times.
3.8.5 Avoid skin contact with HBr because
it is highly toxic and a strong irritant to
eyes and skin.
4. Backup Data.
4.1 Detection Limit Data.
The detection limit was determined by injecting 0.8 μL of a 0.015 μg/mL standard of
ethylene oxide into 1% CS2 in benzene. The
detection limit of the analytical procedure is
taken to be 1.20×10¥5 μg per injection. This is
equivalent to 8.3 ppb (0.015 mg/m3) for the
recommended air volume.
4.2 Desorption Efficiency.
Ethylene oxide was spiked onto charcoal
tubes and the following recovery data was
obtained.
Amount spiked (μg)
4.5
3.0
2.25
1.5
1.5
.75

Amount recovered
(μg)

Percent recovery

4.32
2.61
2.025
1.365
1.38
.6525

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96.0
87.0
90.0
91.0
92.0
87.0

EC15NO91.039

3.3 Sample Preparation.
3.3.1 The front and back sections of each
sample are transferred to separate 2-mL
vials.
3.3.2 Each sample is desorbed with 1.0 mL
of desorbing reagent.
3.3.3 The vials are sealed immediately and
allowed to desorb for one hour with occasional shaking.
3.3.4 Desorbing reagent is drawn off the
charcoal with a disposable pipet and put into
clean 2-mL vials.
3.3.5 One drop of HBr is added to each
vial. Vials are resealed and HBr is mixed well
with the desorbing reagent.
3.3.6 About 0.15 gram of sodium carbonate
is carefully added to each vial. Vials are
again resealed and mixed well.
3.4 Standard Preparation.
3.4.1 Standards are prepared by injecting
the pure ethylene oxide gas into the
desorbing reagent.
3.4.2 A range of standards are prepared to
make a calibration curve. A concentration of
1.0 μL of ethylene oxide gas per 1 mL
desorbing reagent is equivalent to 1.0 ppm
air concentration (all gas volumes at 25 °C
and 760 mm) for the recommended 1 liter air
sample. This amount is uncorrected for
desorption efficiency (See Backup Data Section 4.2. for desorption efficiency corrections).
3.4.3 One drop of HBr per mL of standard
is added and mixed well.
3.4.4 About 0.15 grams of sodium carbonate is carefully added for each drop of
HBr (A small reaction will occur).
3.5 Analysis.
3.5.1 GC Conditions.
Nitrogen flow rate—10mL/min.
Injector Temperature—250 °C
Detector Temperature—300 °C
Column Temperature—100 °C
Injection size—0.8 μL
Elution time—3.9 minutes
3.5.2 Peak areas are measured by an integrator or other suitable means.
3.5.3 The integrator results are in area
units and a calibration curve is set up with
concentration vs. area units.
3.6 Interferences.
3.6.1 Any compound having the same retention time of 2-bromoethanol is a potential
interference. Possible interferences should
be listed on the sample data sheets.
3.6.2 GC parameters may be changed to
circumvent interferences.
3.6.3 There are usually trace contaminants in benzene. These contaminants, however, posed no problem of interference.
3.6.4 Retention time data on a single column is not considered proof of chemical
identity. Samples over the 1.0 ppm target
level should be confirmed by GC/Mass Spec
or other suitable means.
3.7 Calculations

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§ 1910.1047

Occupational Safety and Health Admin., Labor
Amount spiked (μg)

Amount recovered
(μg)

.375
.375
.1875
.094

.315
.312
.151
.070

perature (23 °C). These stored samples were
analyzed over a period of nineteen days.

Percent recovery
84.0
83.2
80.5
74.5

At lower amounts the recovery appears to
be non-linear.
4.3 Sensitivity Data.
The following data was used to determine
the calibration curve.
Injection

0.5×.75 μg/mL

1 .............
2 .............
3 .............
4 .............
X ............

1×1.5 μg/mL

30904
30987
32555
32242
31672

2×3.0 μg/mL

59567
62914
58578
57173
59558

111778
106016
106122
109716
108408

Slope=34.105.

4.4 Recovery.
The recovery was determined by spiking
ethylene oxide onto lot 120 charcoal tubes
and desorbing with 1% CS2 in Benzene. Recoveries were done at 0.5, 1.0, and 2.0 X the
target concentration (1 ppm) for the recommended air volume.

PERCENT RECOVERY
Sample

0.5x

1 .....................................
2 .....................................
3 .....................................
4 .....................................
5 .....................................
X ....................................

1.0x

88.7
83.8
84.2
88.0
88.0
86.5

95.0
95.0
91.0
91.0
86.0
90.5

2.0x
91.7
87.3
86.0
83.0
85.0
87.0

Weighted Average=88.2.

PERCENT RECOVERY
Day analyzed

Refrigerated

1 .........................................................
1 .........................................................
1 .........................................................
1 .........................................................
4 .........................................................
4 .........................................................
4 .........................................................
6 .........................................................
6 .........................................................
8 .........................................................
8 .........................................................
10 .......................................................
10 .......................................................
10 .......................................................
11 .......................................................
11 .......................................................
13 .......................................................
13 .......................................................
13 .......................................................
14 .......................................................
14 .......................................................
18 .......................................................
18 .......................................................
19 .......................................................
19 .......................................................

87.0
93.0
94.0
92.0
92.0
93.0
91.0
92.0
92.0
................
................
91.7
95.5
95.7
................
................
78.0
81.4
82.4
................
................
66.0
68.0
................
................

0.5×.75
μg/mL

Injection .................................

Average .................................
Standard Deviation ................
CV ..........................................

1.4899
1.5826
1.4628
1.4244
1.4899
.0674
.0452

2×3.0
μg/mL
3.1184
3.0447
2.9149
2.9185
2.9991
.0998
.0333

3(.0277) 2 + 3(.0452) 2 + 3(.0333) 2
3+3+3

87.0
93.0
94.0
92.0
91.0
88.0
89.0

92.0
86.0

90.0
82.0

78.5
72.1

64.0
77.0

Tube No.
1 .......................................................
2 .......................................................
3 .......................................................
4 .......................................................
5 .......................................................
6 .......................................................
7 .......................................................
8 .......................................................
9 .......................................................
10 .....................................................
11 .....................................................
12 .....................................................

Time
(minutes)
10
20
30
40
50
60
70
80
90
100
110
120

Percent
breakthrough
(1)
(1)
(1)
1.23
3.46
18.71
39.2
53.3
72.0
96.0
113.0
133.9

1 None.

CV+0.036
4.6 Storage Data.
Samples were generated at 1.5 mg/m3 ethylene oxide at 85% relative humidity, 22 °C and
633 mm. All samples were taken for 20 minutes at 0.05 Lpm. Six samples were analyzed
as soon as possible and fifteen samples were
stored at refrigerated temperature (5 °C) and
fifteen samples were stored at ambient tem-

The 5% breakthrough volume was reached
when 2.6 liters of test atmosphere were
drawn through the charcoal tubes.
5. References.
5.1 ‘‘NIOSH Manual of Analytical Methods,’’ 2nd ed. NIOSH: Cincinnati, 1977; Method S286.
5.2 ‘‘IARC Monographs on the Evaluation
of Carcinogenic Risk of Chemicals to Man,’’
International Agency for Research on Cancer: Lyon, 1976; Vol. II, p. 157.

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EC15NO91.040

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CV =

.7421
.7441
.7831
.7753
.7612
.0211
.0277

1×1.5
μg/mL

Ambient

4.7 Breakthrough Data.
Breakthrough studies were done at 2 ppm
(3.6 mg/m3) at approximately 85% relative
humidity at 22 °C (ambient temperature).
Two charcoal tubes were used in series. The
backup tube was changed every 10 minutes
and analyzed for breakthrough. The flow
rate was 0.050 Lpm.

4.5 Precision of the Analytical Procedure.
The following data was used to determine
the precision of the analytical method:
Concentration

§ 1910.1047

§ 1910.1047

29 CFR Ch. XVII (7–1–09 Edition)

5.3 Sax., N.I. ‘‘Dangerous Properties of Industrial Materials,’’ 4th ed.; Van Nostrand
Reinhold Company. New York, 1975; p. 741.
5.4 ‘‘The
Condensed
Chemical
Dictionary’’, 9th ed.; Hawley, G.G., ed.; Van
Nostrand Reinhold Company, New York,
1977; p. 361.
Summary of Other Sampling Procedures
OSHA believes that served other types of
monitoring equipment and techniques exist
for monitoring time-weighted averages. Considerable research and method development
is currently being performed, which will lead
to improvements and a wider variety of monitoring techniques. A combination of monitoring procedures can be used. There probably is no one best method for monitoring
personal exposure to ethylene oxide in all
cases. There are advantages, disadvantages,
and limitations to each method. The method
of choice will depend on the need and requirements. Some commonly used methods
include the use of charcoal tubes, passive
dosimeters, Tedler gas sampling bags, detector tubes, photoionization detection units,
infrared
detection
units
and
gas
chromatographs. A number of these methods
are described below.

erowe on DSK5CLS3C1PROD with CFR

A. CHARCOAL TUBE SAMPLING PROCEDURES
Qazi-Ketcham method (Ex. 11–133)—This
method consists of collecting EtO on Columbia JXC activated carbon, desorbing the EtO
with carbon disulfide and analyzing by gas
chromatography with flame ionization detection. Union Carbide has recently updated
and revalidated this monitoring procedures.
This method is capable of determining both
eight-hour time-weighted average exposures
and short-term exposures. The method was
validated to 0.5 ppm. Like other charcoal
collecting procedures, the method requires
considerable analytical expertise.
ASTM-proposed
method—The
Ethylene
Oxide Industry Council (EOIC) has contracted with Clayton Environmental Consultants, Inc. to conduct a collaborative
study for the proposed method. The ASTMProposed method is similar to the method
published by Qazi and Ketcham is the November 1977 American Industrial Hygiene Association Journal, and to the method of
Pilney and Coyne, presented at the 1979
American Industrial Hygiene Conference.
After the air to be sampled is drawn through
an activated charcoal tube, the ethylene
oxide is desorbed from the tube using carbon
disulfide and is quantitated by gas chromatography utilizing a flame ionization detector. The ASTM-proposed method specifies a
large two-section charcoal tube, shipment in
dry ice, storage at less
than ¥5 °C, and analysis within three weeks
to prevent migration and sample loss. Two
types of charcoal tubes are being tested—

Pittsburgh Coconut-Based (PCB) and Columbia JXC charcoal. This collaborative study
will give an indication of the inter- and
intralaboratory precision and accuracy of
the ASTM-proposed method. Several laboratories have considerable expertise using the
Qazi-Ketcham and Dow methods.
B. Passive Monitors—Ethylene oxide diffuses into the monitor and is collected in the
sampling media. The DuPont Pro-Tek badge
collects EtO in an absorbing solution, which
is analyzed colorimetrically to determine
the amount of EtO present. The 3M 350 badge
collects the EtO on chemically treated charcoal. Other passive monitors are currently
being developed and tested. Both 3M and DuPont have submitted data indicating their
dosimeters meet the precision and accuracy
requirements of the proposed ethylene oxide
standard. Both presented laboratory validation data to 0.2 ppm (Exs. 11–65, 4–20, 108, 109,
130).
C. Tedlar Gas Sampling Bags-Samples are
collected by drawing a known volume of air
into a Tedlar gas sampling bag. The ethylene
oxide concentration is often determined onsite using a portable gas chromatograph or
portable infrared spectometer.
D. Detector tubes—A known volume of air
is drawn through a detector tube using a
small hand pump. The concentration of EtO
is related to the length of stain developed in
the tube. Detector tubes are economical,
easy to use, and give an immediate readout.
Unfortunately, partly because they are nonspecific, their accuracy is often questionable. Since the sample is taken over a short
period of time, they may be useful for determining the source of leaks.
E. Direct Reading Instruments—There are
numerous types of direct reading instruments, each having its own strengths and
weaknesses (Exs. 135B, 135C, 107, 11–78, 11–
153). Many are relatively new, offering greater sensitivity and specificity. Popular ethylene oxide direct reading instruments include
infrared detection units, photoionization detection units, and gas chromatographs.
Portable infrared analyzers provide an immediate, continuous indication of a concentration value; making them particularly
useful for locating high concentration pockets, in leak detection and in ambient air
monitoring. In infrared detection units, the
amount of infrared light absorbed by the gas
being analyzed at selected infrared wavelengths is related to the concentration of a
particular component. Various models have
either fixed or variable infrared filters, differing cell pathlengths, and microcomputer
controls for greater sensitivity, automation,
and interference elimination.
A fairly recent detection system is
photoionization detection. The molecules are
ionized by high energy ultraviolet light. The
resulting current is measured. Since different substances have different ionization

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Occupational Safety and Health Admin., Labor
potentials, other organic compounds may be
ionized. The lower the lamp energy, the better the selectivity. As a continuous monitor,
photoionization detection can be useful for
locating high concentration pockets, in leak
detection, and continuous ambient air monitoring. Both portable and stationary gas
chromatographs are available with various
types of detectors, including photoionization
detectors. A gas chromatograph with a
photoionization
detector
retains
the
photionization sensitivity, but minimizes or
eliminates interferences. For several GC/PID
units, the sensitivity is in the 0.1–0.2 ppm
EtO range. The GC/PID with microprocessors
can sample up to 20 sample points sequentially, calculate and record data, and activate alarms or ventilation systems. Many
are quite flexible and can be configured to
meet the specific analysis needs for the
workplace.
DuPont presented their laboratory validation data of the accuracy of the QaziKetcham charcoal tube, the PCB charcoal
tube, Miran 103 IR analyzer, 3M #3550 monitor and the Du Pont C–70 badge. Quoting Elbert V. Kring:
We also believe that OSHA’s proposed accuracy in this standard is appropriate. At
plus or minus 25 percent at one part per million, and plus or minus 35 percent below
that. And, our data indicates there’s only
one monitoring method, right now, that
we’ve tested thoroughly, that meets that accuracy requirements. That is the Du Pont
Pro-Tek badge* * *. We also believe that this
kind of data should be confirmed by another
independent laboratory, using the same type
dynamic chamber testing (Tr. 1470)

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Additional data by an independent laboratory following their exact protocol was not
submitted. However, information was submitted on comparisons and precision and accuracy of those monitoring procedures which
indicate far better precision and accuracy of
those monitoring procedures than that obtained by Du Pont (Ex. 4–20, 130, 11–68, 11–133,
130, 135A).
The accuracy of any method depends to a
large degree upon the skills and experience
of those who not only collect the samples
but also those who analyze the samples.
Even for methods that are collaboratively
tested, some laboratories are closer to the
true values than others. Some laboratories
may meet the precision and accuracy requirements of the method; others may con-

§ 1910.1048

sistently far exceed them for the same method.
[49 FR 25796, June 22, 1984, as amended at 50
FR 9801, Mar. 12, 1985; 50 FR 41494, Oct. 11,
1985; 51 FR 25053, July 10, 1986; 53 FR 11436,
11437, Apr. 6, 1988; 53 FR 27960, July 26, 1988;
54 FR 24334, June 7, 1989; 61 FR 5508, Feb. 13,
1996; 63 FR 1292, Jan. 8, 1998; 67 FR 67965, Nov.
7, 2002; 70 FR 1143, Jan. 5, 2005; 71 FR 16672,
16673, Apr. 3, 2006; 71 FR 50190, Aug. 24, 2006;
73 FR 75586, Dec. 12, 2008]

§ 1910.1048 Formaldehyde.
(a) Scope and application. This standard applies to all occupational exposures to formaldehyde, i.e. from formaldehyde gas, its solutions, and materials that release formaldehyde.
(b) Definitions. For purposes of this
standard, the following definitions
shall apply:
Action level means a concentration of
0.5 part formaldehyde per million parts
of air (0.5 ppm) calculated as an eight
(8)-hour time-weighted average (TWA)
concentration.
Assistant Secretary means the Assistant Secretary of Labor for the Occupational Safety and Health Administration, U.S. Department of Labor, or designee.
Authorized person means any person
required by work duties to be present
in regulated areas, or authorized to do
so by the employer, by this section, or
by the OSH Act of 1970.
Director means the Director of the
National Institute for Occupational
Safety and Health, U.S. Department of
Health and Human Services, or designee.
Emergency is any occurrence, such as
but not limited to equipment failure,
rupture of containers, or failure of control equipment that results in an uncontrolled release of a significant
amount of formaldehyde.
Employee exposure means the exposure to airborne formaldehyde which
would occur without corrections for
protection provided by any respirator
that is in use.
Formaldehyde means the chemical
substance, HCHO, Chemical Abstracts
Service Registry No. 50–00–0.
(c) Permissible Exposure Limit (PEL)—
(1) TWA: The employer shall assure
that no employee is exposed to an airborne concentration of formaldehyde
which exceeds 0.75 parts formaldehyde

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