California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4 - Division of Industrial Safety › Subchapter 7 - General Industry Safety Orders › Group 16 - Control of Hazardous Substances › Article 110 - Regulated Carcinogens › Appendix A - Substance Safety Data Sheet for Ethylene Oxide

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
I. SUBSTANCE IDENTIFICATION
(A) Substance: Ethylene oxide.
(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 color: Colorless liquid below
						  10.7° C (51.3° F) or colorless gas with an ether-like odor detectable
						  at approximately 700 parts EtO per million parts of air (700 ppm).
(F) Permissible exposure limit: Exposure may not exceed
						  1 part EtO per million parts of air averaged over the 8-hour work day.
(G) Short term exposure limit: Exposure may not exceed
						  5 parts EtO per million parts of air averaged over a sampling period of 15
						  minutes.
II. HEALTH HAZARD DATA
(A) Routes of exposure. 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 cyanosis (blue or purple coloring
						  of skin). Exposure has also been associated with the occurrence of cancer,
						  reproductive effects, mutagenic changes, neurotoxicity, and
						  sensitization.
(2) 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.
(C) Reporting signs and symptoms: You should inform
						  your employer if you develop any signs or symptoms that you suspect 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. Section
						  3400(d) of the
						  General Industry Safety Orders requires that where the eyes or body of any
						  person may be exposed to injurious corrosive materials (such as liquid EtO or
						  EtO-containing solutions), suitable facilities for quick drenching or flushing
						  of the eyes and body shall be provided within the work area for immediate
						  emergency use.
(B) Skin exposure: If EtO gets on your skin,
						  immediately wash the contaminated skin with water. If EtO wets your clothing,
						  including 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 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.
IV. RESPIRATORS AND PROTECTIVE CLOTHING
(A) Respirators: You may be required to wear a
						  respirator in emergencies, during nonroutine activities, while your employer is
						  installing engineering controls for the reduction of EtO exposures, or when
						  engineering controls are not feasible. As of the effective date of the EtO
						  regulation, 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 (NIOSH) 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 should 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 limit. 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. 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. 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 tightly closed containers in
						  a cool, well-ventilated area, away from heat, sparks, flames, strong oxidizers,
						  alkalies and strong bases, acids, and acetylide-forming metals such as copper,
						  silver, mercury and their alloys.
(C) Sources of ignition such as smoking materials, 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 and should be washed down with
						  water before removal. If you are wearing clothing which is not impermeable to
						  EtO 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 use an emergency deluge shower
						  to remove the EtO.
(G) You should not keep food, beverages, or smoking
						  materials in regulated areas where employee exposures are above the permissible
						  exposure limit.
(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, in emergency procedures, and in 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 determines 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. The exposure records must be 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
						  records to you and your designated representative and to release your medical
						  records to your physician or designated representative upon your written
						  request in accordance with the provisions of Section
						  3204, Access to Employee Exposure
						  and Medical Records.
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, Fungicide, and Rodenticide Act,
						  7 U.S.C.
						  136 et seq. Published in the Federal Register
						  as mandatory provisions by the EPA at 49 FR 15268 on April 18, 1984 and
						  relegated to advisory status at 49 FR 25675 on June 22, 1984 (concurrent with
						  OSHA's publication of the Federal standard for occupational exposure to EtO),
						  these recommended workplace design and workplace practices are intended to help
						  reduce the exposure of hospital and health care workers to EtO to 1 ppm. For
						  the purposes of this appendix, EPA language which could be misinterpreted to
						  impose mandatory provisions for workplace design and work practices has been
						  amended, primarily by the replacement of "must" by "should," in the
						  recommendations which follow:
1. WORKPLACE DESIGN
(a) Installation of gas line hand valves. Hand valves
						  should 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.
A "capture box" should be installed in those workplace
						  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 into which the discharge from
						  the sterilizer is pumped. The "capture box" should 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 needed 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 should be
						  vented to a non-recirculating or dedicated ventilation system or vented to an
						  equipment or other room where workers are not normally present and which is
						  well ventilated. Aerator units should 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 should be vented as described above for existing
						  aerators.
(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 should 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 ventilation system and is positioned no more
						  than one foot above or behind 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 should be
						  installed over the sterilizer door. The hood or metal canopy should 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 should be
						  installed for use even with those sterilizers that have a purge cycle.
(f) Ventilation of sterilizer relief valve. Sterilizers
						  are typically equipped with a safety relief device to release gas in case of
						  increased 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, nor 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 that uses EtO for the sterilization of equipment and supplies should
						  have a ventilation system which enables compliance with the recommendations of
						  section (b) through (f) in the manner described in these sections. Thus, each
						  affected hospital and health care facility should have or install a
						  non-recirculating or dedicated ventilation system or have available a well
						  ventilated 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 should be installed to alert personnel of
						  ventilation system failures, i.e., when the ventilation fan motor is not
						  working.
2. WORKPLACE PRACTICES
All the workplace practices discussed in this unit
						  should 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 should 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 valve
						  position.
[vii] Check hoses, filters, and valves for leaks with a
						  fluorocarbon leak detector (for those sterilizers using the 88 percent
						  chlorofluorocarbon and 12 percent ethylene oxide mixture).
(b) Restricted access area.
[i] Areas involving use of EtO should be designated as
						  restricted access areas. They should be identified with signs or floor marks
						  near the sterilizer door, aerator, vacuum pump floor drain discharge, and
						  in-use cylinder storage.
[ii] All personnel should 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
						  should 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
						  15-minute 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 should the second period be shortened to less than
						  15 minutes.
(d) Chamber unloading procedures.
[i] Procedures for unloading the chamber should 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 off-gassing exposure.
(e) Maintenance. A written log should be instituted and
						  maintained documenting the date of each leak detection and any maintenance
						  procedures undertaken.
[i] Leak detection. Sterilizer door gaskets, cylinder
						  and vacuum piping, hoses, filters, and valves should 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 gasoline
						  entrance port to the sterilizer, while the sterilizer door is open and the
						  solenoid valves are in a closed position.
[ii] Maintenance procedures. Sterilizer/aerator door
						  gaskets, valves, and fittings should be replaced when necessary as determined
						  by maintenance personnel in their bi-weekly checks; in addition, visual
						  inspection of the door gaskets for cracks, debris, and other foreign substances
						  should be conducted daily by the operator.