- Standard Number:
OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
August 7, 1995
Lois M. Francis, RN
Employee Health Nurse
Doctors Regional Medical Center
621 Pine Street Poplar
Bluff, Missouri 63901
Dear Ms. Francis:
This letter is in response to your inquiry regarding the interpretation of the medical examinations and consultations for employees who are hired for areas that have ethylene oxide. This is found in the ethylene oxide standard 29 CFR 1910.1047 (Mandatory) under paragraph (i)(2)(ii). Appendix C to 1910.1047 provides medical surveillance guidelines for ethylene oxide (Non-Mandatory).
According to 29 CFR 1910.1047 Section (i)(2)(ii) OSHA requires inclusion of the following elements in the medical examination:
(1) A medical and work history with special emphasis directed to symptoms related to the pulmonary, hematologic, neurologic and reproductive systems and the eyes and skin.
(2) A physical examination with particular emphasis given to pulmonary, hematologic, neurologic, and reproductive systems 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.
The medical examination requires that the examining personnel emphasized the pulmonary, hematologic, neurologic, and reproductive systems and to the eyes and skin. The only mandatory laboratory test required by the standard is the complete blood count. Any additional laboratory or other diagnostic test which includes pregnancy testing and fertility testing should be determined by the examining physician. This would require knowledge of the health effects associated with ethylene oxide exposure.
Although Appendix C provides medical surveillance guidelines for ethylene oxide, they are nonmandatory and have been provided as examples. In situations where a respirator is required, it has been suggested that additional tests the examining physician should consider would include evaluation of the cardiovascular function, a baseline chest x-ray to be repeated at 5 year intervals, and a pulmonary function test to be repeated every three years. The pulmonary function tests should include measurement of the employee's forced vital capacity (FVC), forced expiratory volume at one second (FEV1), and calculation of the FEV1/FVC ratios.
The examining physician is given the latitude to establish medical protocols and select additional diagnostic tests which are deemed necessary to aid in the establishment of a medical surveillance program and/or provide medical consultation. 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. If any additional assistance is required, please do not hesitate to contact the Office of Occupational Medicine.
Sincerely,
Melissa A. McDiarmid, M.D., M.P.H
Director, Office of Occupational Medicine
June 28, 1995
Occupational Safety and Health Administration
ATTENTION: Marsha Drumm
Regional Administrator
1100 Main Street, Suite 800
Kansas City, MO 64105
Dear Madam:
Doctors Regional Medical Center would like to request a written interpretation on the standard on Ethylene Oxide. The specific area that we are requesting a clarification involves the medical examinations and consultations for those employees who are specifically hired for areas that have ethylene oxide sterilizers or transfer into that area to become permanent employees of those areas. Would you please interpret the extent of the physical exam particularly emphasizing the pulmonary and the neurological areas. We want to follow these guidelines of your recommendations but we are looking at the cost of some of this testing and examination. Exactly what is necessary in these areas on the initial and yearly physicals as compared to an exposure physical.
Please send this interpretation to:
Lois M. Francis, RN
Employee Health Nurse
Doctors Regional Medical Center
621 Pine Street Poplar
Bluff, MO 63901
We will appreciate your prompt attention to this matter so that we can progress with our program.
Sincerely,
Lois M. Francis, RN
Employee Health Nurse