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 C - Medical Surveillance Guidelines for Ethylene Oxide

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
I. ROUTE OF ENTRY
Inhalation.
II. TOXICOLOGY
Clinical evidence of adverse effects associated with
						  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 EtO also indicate damage to the genetic material (DNA). These
						  include hemoglobin alkylation, unscheduled 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.
Most reported acute effects of occupational exposure to
						  EtO are due to contact with EtO in liquid phase. The liquid readily penetrates
						  rubber and leather, and will produce blistering if clothing or footwear
						  contaminated with EtO are not removed.
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 examination. 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] Compete 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 X-ray 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) and
						  forced expiratory volume at one second (FEV1), the calculation of the ratio of
						  FEV1 to FVC, and the calculation of the ratio of measured FVC and measured FEV1
						  values to predicted FVC and FEV1 values based on 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 examinations 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 information: 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 duties and the employee's fitness to
						  wear personal protective equipment, if 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.