**THE NATIONAL INSTITUTES OF HEALTH**

**ETHYLENE OXIDE PROGRAM**

![](media/image1.wmf)

**\
**

# Technical Assistance Branch {#technical-assistance-branch .unnumbered}

**Division of Occupational Health & Safety**

##  {#section .unnumbered}

## Reviewed June 2007 {#reviewed-june-2007 .unnumbered}

TABLE OF CONTENTS

####### THE ETO PROGRAM

+-----------------------------------+-----------+----------------------+
| ## [Section 1.0]{.unde            |           | ### **               |
| rline} {#section-1.0 .unnumbered} |           | [PAGE]{.underline}** |
+-----------------------------------+-----------+----------------------+
| 1.1 Purpose                       |           | 3                    |
+-----------------------------------+-----------+----------------------+
| 1.2 Scope and Application         |           | 3                    |
+-----------------------------------+-----------+----------------------+
| 1.3 Background                    |           | 3                    |
+-----------------------------------+-----------+----------------------+
|                                   |           |                      |
+-----------------------------------+-----------+----------------------+
| ## [Section 2.0]{.unde            |           |                      |
| rline} {#section-2.0 .unnumbered} |           |                      |
+-----------------------------------+-----------+----------------------+
| 2.0 Definitions                   |           | 4                    |
+-----------------------------------+-----------+----------------------+
|                                   |           |                      |
+-----------------------------------+-----------+----------------------+
| ### **[Section 3.0]{.underline}** |           |                      |
+-----------------------------------+-----------+----------------------+
| 3.0 Key Provisions                |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.1 Exposure Monitoring           |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.2.1 Initial Monitoring          |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.2.2 Compliance Plan             |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.2.3 Overexposures               |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.2.4 Employee Notification       |           | 5                    |
+-----------------------------------+-----------+----------------------+
| 3.3 Methods of Compliance         |           | 6                    |
+-----------------------------------+-----------+----------------------+
| 3.3.1 Engineering Controls        |           | 6                    |
+-----------------------------------+-----------+----------------------+
| 3.3.2 Personal Protective         |           | 6                    |
| Equipment                         |           |                      |
+-----------------------------------+-----------+----------------------+
| 3.3.3 Respiratory Protection      |           | 6                    |
+-----------------------------------+-----------+----------------------+
| 3.3.4 Administrative Controls     |           | 6                    |
+-----------------------------------+-----------+----------------------+
| 3.4 Regulated Areas               |           | 7                    |
+-----------------------------------+-----------+----------------------+
| 3.5 Communication of ETO Hazards  |           | 7                    |
+-----------------------------------+-----------+----------------------+
| 3.6 Employee Training             |           | 7                    |
+-----------------------------------+-----------+----------------------+
| 3.7 Medical Surveillance          |           | 8                    |
+-----------------------------------+-----------+----------------------+
| 3.8 Emergency Situations          |           | 8                    |
+-----------------------------------+-----------+----------------------+
| 3.9 Record Keeping                |           | 8                    |
+-----------------------------------+-----------+----------------------+
|                                   |           |                      |
+-----------------------------------+-----------+----------------------+
| ##### [Section 4.0]{.underline}   |           |                      |
+-----------------------------------+-----------+----------------------+
| 4.0 Applicability                 |           | 9                    |
+-----------------------------------+-----------+----------------------+
|                                   |           |                      |
+-----------------------------------+-----------+----------------------+
| #### [Section 5.0]{.underline}    |           |                      |
+-----------------------------------+-----------+----------------------+
| 5.0 References                    |           | 9                    |
+-----------------------------------+-----------+----------------------+
|                                   |           |                      |
+-----------------------------------+-----------+----------------------+
| ######                            |           |                      |
+-----------------------------------+-----------+----------------------+
| **[Appendices]{.underline}**      |           |                      |
+-----------------------------------+-----------+----------------------+
| Appendix 1 - Ethylene Oxide       |           |                      |
| Surveillance Protocol             |           |                      |
+-----------------------------------+-----------+----------------------+
| Appendix 2 - Ethylene Oxide       |           |                      |
| Medical Surveillance              |           |                      |
+-----------------------------------+-----------+----------------------+
| Appendix 3 - Ethylene Oxide       |           |                      |
| Information and Training Plus     |           |                      |
| MSDS                              |           |                      |
+-----------------------------------+-----------+----------------------+
| Appendix 4 - Emergency Procedures |           |                      |
| For Ethylene Oxide Release        |           |                      |
+-----------------------------------+-----------+----------------------+

**THE NATIONAL INSTITUTES OF HEALTH**

**DIVISION OF OCCUPATIONAL HEALTH AND SAFETY**

**ETHYLENE OXIDE PROGRAM**

# INTRODUCTION

**1.1 Purpose**

The Division of Occupational Health and Safety (DOHS), Technical
Assistance Branch (TAB), has established an ethylene oxide (EtO)
surveillance program at the National Institutes of Health (NIH). The EtO
program is designed to: 1) identify and quantify potential exposure
levels for employees who work in EtO sterilization facilities, and 2)
documents the effectiveness of the controls that are being used to
minimize exposures.

**1.2 Scope and Application**

The EtO program establishes guidelines for implementation and compliance
with the requirements of the Occupational Safety and Health
Administration (OSHA) EtO standard, 29 CFR 1910.1047. This program is
administered by the DOHS, and applies to all occupational exposures to
EtO at the NIH. The EtO program outlines key provisions of the standard
and provides procedures in place at the NIH for employee exposure
monitoring, methods of compliance/controls, respirators and protective
clothing, emergency situations, medical surveillance, communication of
EtO hazards (labeling and posting hazards), training and record keeping.

All EtO sterilizers, aerators, and gas sources used at the NIH are
evaluated and monitored to ensure that they have been designed,
installed, or modified to help the facility meet the OSHA standard and
to otherwise minimize personnel exposure to EtO.

**1.3 Background**

EtO is a flammable, colorless liquid or gas with an ether-like or sweet
odor that is detectable only above the PEL. EtO is produced in large
volumes and is used to make other chemicals, such as ethylene glycol.
Control of insects on stored agricultural products, such as nuts and
spices, is achieved with small amounts of EtO. Hospitals use very small
amounts of EtO to sterilize medical equipment and supplies. Synonyms for
EtO include: Dimethylene oxide, 1,2-Epoxy ethane, and Oxirane.

EtO is irritating to the respiratory tract, skin, and eyes. Inhalation
is the most common route of EtO exposure and high concentrations may
cause coughing, dizziness, drowsiness, headache, nausea, sore throat,
and vomiting. Repeated or prolonged contact may cause skin
sensitization. Eye contact may cause redness, pain, or blurred vision.
EtO is a suspected human carcinogen.

**2.0 DEFINITIONS**

For evaluating employee exposures to EtO, the NIH uses exposure criteria
established by OSHA as defined below:

**Action Level (AL) --** An airborne concentration of 0.5 ppm EtO
average as an 8-hour TWA.

**Permissible Exposure Limit (PEL) --** A limit on workplace exposure of
one (1) part EtO per million parts of air (1 ppm) as an eight-hour
time-weighted average (8-hour TWA).

**Short Term Exposure Limit (STEL) --** An excursion limit of 5 ppm EtO
averaged over a sampling period of 15 minutes.

**Regulated Area --** Areas identified where occupational exposures may
exceed the TWA. These areas must be clearly marked and only authorized
personnel allowed to enter.

**3.0 KEY PROVISIONS**

### **3.1 Exposure Monitoring/Frequency**

Routine monitoring of EtO sterilizers and associated equipment, work
environments and NIH employees, is performed to evaluate employee
exposures and to ensure the continuing effectiveness of engineering
control measures, work practices, and equipment maintenance. An EtO
surveillance program has been developed to monitor occupational
exposures to EtO at NIH. *(See Appendix 2)*

In areas of the NIH where EtO is utilized, employees will be monitored
annually to determine their exposure relative to the AL and the PEL
(8hr-TWA and STEL). Employee monitoring will be extrapolated to
represent other employees performing the identical job task in the same
laboratory. Employees and their designated representatives may observe
all monitoring.

If representative samples are used to determine the employee's exposure
to EtO, the measurements obtained will be representative of the
employee's full workday, or a fraction thereof. Short-term or grab
samples, except for the STEL determination, will be considered screening
samples to be followed up with sampling for the duration of the workday
exposures.

An employee health complaint related to EtO exposure, e.g., symptoms of
respiratory, gastrointestinal or dermal conditions, will initiate
personal monitoring of that employee and background monitoring of the
job task. Monitoring of employees reporting signs or symptoms will be
done promptly.

Monitoring will be repeated annually and each time there is a change in
a work process or procedure, equipment, or control measures which may
result in new or additional exposures to EtO. Monitoring will cease if
EtO sterilization is no longer utilized in the facility.

**3.2 Monitoring Results**

Based upon the EtO monitoring results, the need for further action is
determined. Further action may include periodic monitoring, development
of a compliance plan, participation in a medical surveillance program,
and implementation of engineering and/or administrative control methods.

### **3.2.1 Initial Monitoring**

### 

### If initial monitoring reveals employee exposures at or above the AL, periodic exposure monitoring and medical surveillance will be implemented. Employees will be provided information and training on EtO at the time of initial assignment and at least annually thereafter.

### 

### **3.2.2 Compliance Plan**

If employee exposure exceeds the TWA or STEL, a written program should
be implemented to reduce exposures to or below the TWA and or the STEL,
by means of engineering and work practice controls supplemented with the
use of respiratory protection on an interim basis.

**3.2.3 Overexposures**

In areas where EtO monitoring has been conducted and the EtO TWA or STEL
levels have been exceeded, the NIH will:

-   Use engineering controls and work practices to reduce and maintain
    employee exposures at or below the TWA or STEL. These controls and
    practices may be supplemented by the use of respirators where
    necessary.

-   Establish and implement a written compliance program to achieve
    employee exposure at or below the TWA or STEL.

-   Establish exposure monitoring and training programs for employees
    with EtO exposure above the STEL. Repeat employee monitoring at
    least every 3 months until the exposure is below the AL .

-   Identify as a *regulated area* any location where the airborne
    concentration of EtO is expected to exceed the TWA or STEL.

-   Place warning labels on containers capable of releasing EtO to the
    extent hat an employee's potential exposure would exceed the TWA or
    STEL.

Note: Employee rotation is prohibited as a means of compliance with the
TWA or STEL.

### **3.2.4 Employee Notification of Monitoring Results**

The affected employee and their supervisor will be notified with a
written report of the results of the monitoring conducted by DOHS within
15 working days.

**3.3 Methods of Compliance/Controls**

**3.3.1 Engineering Controls**

Engineering and work practice controls will be implemented to reduce and
maintain employee exposures at or below the AL, TWA, and STEL.
Ventilation is the principal means for controlling EtO emissions at the
NIH. EtO exhaust is vented to a dedicated exhaust or non-recirculating
ventilation system.

### **3.3.2 Personal Protective Equipment**

Where eye or skin contact with liquid EtO or EtO solutions may occur,
the NIH will select and provide, at no cost to the employee, appropriate
personal protective equipment (PPE) in accordance with (IAW) 29 CFR
1901.132 and 1901.133. Appropriate PPE may include: neoprene or butyl
rubber gloves, vinyl aprons, or protective clothing (impermeable), full
face shields, and safety goggles to protect any part of the body that
may come in contact with EtO. The supervisor will ensure that the
employee properly wears the PPE provided and that it is worn as
required.

### **3.3.3 Respiratory Protection**

Respirators may be used to control EtO exposures only under the
following circumstances: during the installation of feasible engineering
and work practice controls; during maintenance, repairs, and other
operations for which engineering controls are not feasible; in work
situations where feasible engineering and work practice controls do not
reduce exposures below the TWA and STEL; and in emergencies. In
situations where respiratory protection is required the NIH Respiratory
Protection Program in association with the OSHA Respiratory Protection
Standard, 29 CFR 1910.134 (b), (d), (e), and (f) will be instituted.

**3.3.4 Administrative Controls**

Safe working conditions in NIH EtO facilities are obtained through
proper work practices and adequately designed and maintained equipment.
Supervisors should as much as possible, reduce the amount of time an
employee may spend in the area where the EtO sterilizer is located.

### **3.4 Regulated Areas**

Employers must identify areas where occupational exposures exceed the
TWA. These areas must be clearly marked and only authorized personnel
allowed to enter.

### **3.5 Communication of EtO Hazards**

Employees are informed of EtO exposure hazards, potential adverse health
effects, and methods for protecting themselves from exposure to EtO.
This information is communicated in association with OSHA regulations as
stipulated in 29 CFR 1910.1047 (Ethylene Oxide) and in 29 CFR 1910.1200
(Hazard Communication). In addition, signs and labels are posted that
clearly indicate EtO's carcinogenic and reproductive hazards and outline
good work practices. Such signs and labels are posted: 1) in the
immediate area of the sterilizers, 2) above EtO supply cylinders, and 3)
areas with associated equipment. Information and training must be given
initially to employees who may be exposed at or above the AL and at
least annually thereafter.

**3.6 Employee Training**

DOHS will provide initial and annual training to all employees
potentially exposed to EtO at any level. All new hires will be provided
information on EtO.

The training will include information on:

-   The requirements of the OSHA EtO standard with an explanation of its
    contents, including Appendices A and B;

-   Any operations in the employee's work area where EtO is present;

-   The location and availability of the written EtO final rule;

-   The medical surveillance program with an explanation of the
    information in Appendix C;

-   Methods and observations that may be used to detect the presence or
    release of EtO;

-   The physical and health hazards of EtO; and

-   The measures employees may take to protect themselves from hazards
    associated with EtO exposures, including specific procedures the NIH
    has implemented to protect employees from exposures to EtO, such as
    work practices, emergency procedures and PPE to be used; and

-   The details of the hazard communication program developed by the
    employer, including an explanation of the labeling system and how
    employees may obtain and use the appropriate hazard information.

Training is a key part of the EtO program and will be carried out
diligently. *(See Appendix 4 -- EtO Information and Training Protocol)*

### **3.7 Medical Surveillance**

Once activated, medical surveillance will be conducted by a licensed
health care provider through the Occupational Medical Service (OMS).
Employees will receive a medical examination: 1) before assignment to an
area where exposure is at or above the AL; 2) annually if they are
exposed at this level for 30 days or more during the year; 3) upon
request, if a employee has developed symptoms suggesting overexposure or
wants medical advice concerning the effects of EtO exposure on his or
her ability to produce a healthy child; and 4) at the time a employee's
employment ends in an area of potential exposure. Employees, who are
exposed to EtO at or above the AL or in an emergency situation, are
automatically enrolled in the OMS Medical Surveillance Protocol. *(See
Appendix 2)*

Due to successive monitoring of clinical center employees that has
resulted in documented, ambient EtO concentrations well below the
established OSHA PEL, the OMS Medical Surveillance Protocol has been
deactivated. If the DOHS identifies employee exposure to EtO at the AL,
then the OMS Medical Surveillance Protocol will be reactivated.

**3.8 Emergency Situations**

A written plan for EtO emergency situations has been developed for each
workplace where there is a possibility of an emergency. Appropriate
portions of the plan will be implemented in the event of an emergency.
*(See Appendix 4 -- Emergency Procedures for EtO Release)*

### **3.9 Record Keeping**

Exposure records will be retained for 30 years; medical records must be
kept for the employee's duration of employment, plus 30 years.
Employees, former employees, and their designated representatives may
have access to records, upon request.

The TAB, DOHS maintains and updates records of all monitoring data
obtained to measure employee exposures to EtO. The records include:

a.  Date measurements were obtained;

b.  Operations of process being monitored;

c.  Method of sampling and of analysis used;

d.  Number, duration, time, and results of samples taken;

e.  Types of PPE used;

f.  Employee names, Institute, Center, and Department (ICD), area
    supervisor, job, social security number, and exposure estimate of
    the employee whose exposures are represented by the actual
    monitoring results

### **4.0 Applicability**

The OSHA standard generally applies to all occupational exposures to
EtO. Exceptions, and therefore excluded workplaces, include those in
which the processing, use, or handling of products containing EtO will
not result in airborne concentrations at or above the AL. An employer
who claims exemption from the standard must keep records that document
this determination.

##### 5.0 References

U.S. Department of Labor [OSHA Safety and Health Standards (29 CFR
1910]{.underline}). U.S. Government Printing Office, Washington, D.C.,
1991

Lamontagne, A.D., Kelsey, K., Christiani, D. and Plantamura, D.
[Ethylene Oxide Health and Safety Manual: Training and Reference
Materials on the Safe Use of Ethylene Oxide in Sterilization
Facilities,]{.underline} 2^nd^ edition.

> APPENDIX 1

#  {#section-4 .unnumbered}

# ETHYLENE OXIDE SURVILLANCE PROTOCOL {#ethylene-oxide-survillance-protocol .unnumbered}

ETHYLENE OXIDE SURVEILLANCE PROTOCOL

Purpose

To evaluate the exposure of NIH employee to ethylene oxide (EtO)
resulting from EtO sterilization or servicing procedures.

# Introduction

Presently, there are two types of EtO gas sterilizers used at the

NIH: (1) automatic, general purpose sterilizers that are supplied by
compressed-gas cylinders or single-dose cartridges, and (2) sterilizers
that use glass ampules.

All ethylene oxide sterilization facilities at NIH are surveyed annually
to determine if the employees that operate the sterilizers and those
that work in the immediate area are exposed to excessive levels of EtO.
The goal of the program is to reduce personal exposures to the lowest
level possible through the use of approved equipment, adequate
engineering controls, and good work practices

The survey results serve to evaluate the effectiveness of engineering
controls and work practices. It provides documentation of surveillance
activities for The Joint Commission for Accreditation of Health Care
Organizations (JCAHO) and defines compliance with Occupational Safety
and Health Administration (OSHA) statutes.

# Criteria

The current OSHA permissible exposure limit (PEL) for ethylene oxide (29
CFR, Section 1910.1047) is 1 part per million (ppm) based on an 8 hour
time weighted average (TWA) exposure. There is also a short-term
exposure limit (STEL) of 5 ppm for 15 minutes. This means that the
average EtO concentration during any 15-minute period of the workday
should not exceed 5 ppm. An EtO concentration one half of the PEL is
defined as the \"action level\" (0.5 ppm).

Employees exposed to EtO at and above this level for at least thirty
days a year are required to participate in a medical surveillance
program and monitoring must be done every six months. There are
additional compliance requirements if employee exposure exceeds the PEL
or STEL. Detailed information on these, requirements are found in the
OSHA Standard 29 CFR 1910.1047 located in Appendix 1.

Analytical Methods

This method involves the use of passive dosimeters (#3550/3551)
manufactured by the Minnesota Mining and Manufacturing Co. (3M). These
dosimeters adsorb ethylene oxide vapors on chemically treated activated
charcoal. The contaminants are then desorbed and quantified by gas
chromatography. All samples will be analyzed by an accredited American
Industrial Hygiene Association Laboratory.

# Sampling Strategy

A sampling strategy will be developed for each location monitored
because of the specific conditions and uniqueness of each sampling
situation. The employee with the highest risk of exposure will be
sampled and samples will be obtained during periods of maximum EtO
concentration by using all available knowledge about the area, employees
and process being sampled.

# Monitoring Procedure

Scheduling for monitoring each facility will be done with the supervisor
of each area (see Table 1). Routine monitoring of the sterilizer and
associated equipment as well as the work environment will be conducted
to check on employee exposure and to ensure the continuing effectiveness
of engineering control measures, work practices, and equipment
maintenance.

Consecutive sampling, area and personal, will be conducted during the
entire work shift. All samples will be taken in areas that are
representative of the concentration at which employees are exposed
during normal and routine use of EtO.

Personal samples will be taken in the \"breathing zone\" of the
employee. The employee will wear a small badge clipped to his/her collar
for either 15 minutes (to test the Short Term Exposure Limit (STEL) of 5
ppm) or an 8-hour shift (to test the Time Weighted Average (TWA)
exposure limit of 1 ppm). The badges will be worn during operations with
the highest potential for exposures. Employees who change the EtO
cylinders will be included in periodic STEL checks. Area monitoring will
be conducted at various fixed locations in the workplace.

A sampling data sheet (Attachment l) will be completed for each area
monitored. These data sheets will indicate the locations of area
monitors and identify operator, including social security number that
works regularly in the EtO sterilization area. The employee will be
notified of his/her monitoring results within 15 days of receipt from
laboratory.

Passive dosimeters will be stored in a cool place away from chemical
contaminants until used. After use, the dosimeters will be analyzed as
soon as possible by the manufacturer or an American Industrial Hygiene
Association (AIHA) accredited laboratory. Samples will be shipped no
later than one day after the sample has been collected. Samples will be
kept under refrigeration until ready for analysis.

# REPORT

Supervisors of areas being monitored will be immediately informed of
equipment deficiencies and unsafe work practices that may contribute to
potential harmful exposures. It is the responsibility of the supervisors
in each facility to initiate and follow to completion the
recommendations made in the final report. Copies of all final reports
will be sent to the OMS Medical Director; to the responsible
supervisor(s) in each area (see Table 1); and to the safety and health
consultant assigned to the ICD that is responsible for the operation of
the EtO facility.

In the clinical center, corrective actions requiring engineering support
will be coordinated through the Building Services Manager. The following
persons will be notified of findings that need immediate attention and
will also receive copies of the final report of the survey conducted in
the Central Hospital Supply facility:

Environmental Safety Officer, CC

Chief, Materials Management Department, CC

Chief, Central Hospital Supply Section, MM, CC

In all other areas of NIH, engineering support will be coordinated
through the appropriate Office of Research Facilities Development and
Operations (ORF) coordinator. Safety and health consultants assigned to
ICDs where facility changes are needed will provide assistance and will
monitor the progress of the project to completion.

It is the responsibility of the Clinical Center ESO and/or Safety
Committee to provide the DOHS, with an annual (or more frequently if
necessary) updated list of EtO gas usage areas within the Clinical
Center. In other areas, this information will be provided by the ICD\'s
safety and health consultant or by other appropriate mechanism

REFERENCE

1.  U.S. Department of Labor OSHA Safety and Health Standards (29 CFR
    1910). U.S. Government Printing Office, Washington D.C., 1987

#  {#section-5 .unnumbered}

#  {#section-6 .unnumbered}

#  {#section-7 .unnumbered}

# APPENDIX 2 {#appendix-2 .unnumbered}

# ETHYLENE OXIDE MEDICAL SURVEILLANCE {#ethylene-oxide-medical-surveillance .unnumbered}

ETHYLENE OXIDE MEDICAL SURVEILLANCE

Currently, the ethylene oxide medical surveillance program is inactive
due to consecutive low or less than detected results on the NIH campus.
If surveillance results exceed PEL then the EtO medical surveillance
program will be activated by Occupational Medical Service.

I. Background

In the health care setting, ethylene oxide is commonly used for
sterilizing medical supplies and equipment. At room temperature and
normal atmospheric pressure, it is a colorless gas with a characteristic
ether-like odor. The threshold of odor perception is variable with a
mean odor concentration of 700 parts per million. The threshold commonly
wanes with chronic exposure.

Acute toxicity in humans may consist of irritation of the eyes,
respiratory tract and skin, headache, nausea, vomiting, diarrhea,
neurological signs and symptoms such as seizures, peripheral neuropathy,
gait disturbances, hypesthesia and changes in lymphocytosis. In
addition, many individuals complain of a peculiar taste.

The effects of chronic exposure/toxicity in humans are not as well
established. The human studies in the literature are contradictory and
the conclusions reached are controversial, but they suggest that
ethylene oxide exposure may lead to increased sister chromatic exchange,
leukemia, solid tumors of the gastrointestinal and genito-urinary
systems, and spontaneous abortions.

Current OSHA recommendations define the \"action level\" as a mean
concentration of airborne ethylene oxide of less than O.5 parts per
million calculated as an eight-hour time-weighted average (TWA) and the
permissible exposure limit (PEL) as an airborne concentration of
ethylene oxide not to exceed one part ethylene oxide per million parts
of air as an eight-hour time-weighted average.

II\. Eligibility

All employees who are or may be exposed to ethylene oxide at or above an
airborne concentration of 0.5 ppm calculated as an eight-hour
time-weighted average for at least 30 days a year.

All employees who have been exposed to ethylene oxide during an
emergency.

III\. Identification of eligible employees

The Division of Occupational Health and Safety (DOHS) will submit a list
of employees based on the results of environmental measurements obtained
at worksites where ethylene oxide is used.

IV\. Frequency of medical examinations and consultations.

A. Employees at or above the action level

> 1\. Pre-employment
>
> 2\. Annually
>
> 3\. Development of signs or symptoms indicating possible over-exposure
> to ethylene oxide
>
> 4\. Termination from an ethylene oxide worksite

B. Employees exposed during an emergency

1\. As medically indicated

V. Content of medical examination

A. Pre-employment examination

1)  Complete work history with special attention to prior work exposures

2)  Complete medical history with special attention to pulmonary,
    neurologic, hematologic, hepatic and reproductive systems

3)  Complete physical examination

4)  Laboratory evaluation: CBC with differential and SMAC.

5)  Additional tests as medically indicated.

B. Annual examination

1)  Interim work history with special attention to work practices, job
    description, estimated exposure and signs or symptoms indicating
    possible over-exposure to ethylene oxide.

2)  Interim medical history with special attention to pulmonary,
    neurologic, hematologic and reproductive systems and the skin and
    eyes.

3)  Physical examination to include the eves, lungs, abdomen, skin and
    neurologic system.

4)  Laboratory evaluation: CBC with differential. Additional tests as
    medically indicated.

C. Development of signs or symptoms of over-exposure or exposure during
an emergency.

1)  Work history with special attention to work practices and/or nature
    of exposure during the emergency.

2)  Physical examination to include the eyes, lungs, abdomen, skin and
    neurologic system.

3)  Laboratory evaluation: CBC with differential, SMAC to assess hepatic
    function, additional tests as medically indicated.

4)  Removal from further ethylene oxide exposure until signs and
    symptoms resolve.

5)  Follow-up as medically indicated.

6)  Notify DOHS.

D. Termination from an ethylene oxide worksite per annual examination.

E. Reproductive evaluation, if medically indicated.

1)  Work history with special attention to ethylene oxide exposure.

2)  Medical history with special attention to reproductive and
    genito-urinary systems.

3)  Physical examination.

4)  Laboratory evaluation may include pregnancy testing if medically
    indicated.

5)  Referral for fertility evaluation if medically indicated.

Vl. Medical Documentation

A. Pre-employment Work and Medical History: Ethylene Oxide

> Surveillance: Preplacement Work and Medical history, Attachment I.
>
> B. Interim Work and Medical History: Ethylene Oxide Surveillance:
>
> Interim Medical Work and Medical History, Attachment II.
>
> C. Physical Examination. Ethylene Oxide Surveillance: Physical Exam,
> Attachment III.

VII\. Notification of employees of medical surveillance results.

A. Physical examination and laboratory results.

1)  Normal findings: Verbal notification at the end of the physical
    examination by the examining medical personnel.

2)  Findings suggestive of ethylene oxide over-exposure: Verbal
    notification at the end of the physical examination by the examining
    medical personnel and written notification within 15 days of the
    physical examination by the OMS physician heading the surveillance
    program.

VIII\. Ethylene Oxide Surveillance Review

A. Annual review with the appropriate members from OMS and DOHS.

1)  Review latest OSHA/NlOSH recommendations.

2)  Review environmental sampling data obtained by DOHS with special
    attention given to an employee\'s representative exposure level or
    anticipated exposure level.

3)  Review of medical literature.

# APPENDIX 3 {#appendix-3 .unnumbered}

# ETHYLENE OXIDE INFORMATION AND TRAINING {#ethylene-oxide-information-and-training .unnumbered}

**Training and Information Protocol**

**for NIH Personnel Working With Ethylene Oxide (ETO)**

This appendix reviews the mandatory information required by OSHA in 29
CFR 1910.1047 (j) (3)\-- Communication of EtO Hazards to Employees to
Employees: Information and Training.

## Program Overview

The NIH has developed an in-service program for personnel who may work
with Ethylene Oxide or may be potentially exposed in the course of their
activities. This training program is provided through the Technical
Assistance Branch, DOHS in cooperation with the Safety Operations
Support Branch.

The program consists of three parts. Part I provides a comprehensive
overview of the hazards associated in working with ETO, safe work
practices and the steps to be taken in the event of an emergency. Part
II, is an overview program for support staff who may work around but not
directly with ETO. Part III is an orientation package for new employees
working with ETO conducted by the designated, responsible supervisor.

All personnel working with Ethylene Oxide or who may work in close
proximity to ETO sterilizers are required to participate in Part I of
the NIH ETO Training Program. This training is provided on an annual
basis, with a mid-year update being provided six months afterward.

Part II of the program provides an overview of use of ETO in clinical
and research areas for support staff and others who may work in areas
where ETO is used but are not occupationally exposed. T his program is
provided on an-as-needed basis.

In each area where ETO is used or stored, the designated, responsible
supervisor maintains a site-specific safety orientation package. This
package will include a copy of the written ETO program, standard
operating procedures, hazard information and warnings and steps to be
taken in the event of an emergency. All new personnel working with ETO
must receive this safety orientation before beginning work. The
designated, responsible supervisor will be required to document this
orientation. This program will be audited on a semi-annual basis during
regular scheduled training.

The NIH Ethylene Oxide Safety Training Program is consistent with the
NIH Hazard Communication Program.

The Technical Assistance Branch will maintain a complete copy of the
training materials. The Division of Occupational Health and Safety will
maintain training program documentation and attendance records.

# Program Content

The information provided in the overall program includes, but is not
limited to:

1)  The availability of the ETO standard to employees. An overview of
    the NIH Hazard Communication Program and the ETO medical
    surveillance program conducted by the Occupation Medical Service
    (OMS).

2)  The physical and health effects of both acute and chronic exposure
    to ETO. Methods used to detect the presence of ETO\--personnel
    monitoring and area alarms.

3)  The availability of information on ETO. Signs used to indicate the
    presence of ETO\--regulated areas.

4)  The rationale for and results of ETO exposure monitoring done in the
    particular location

5)  Accepted work practices with ETO to minimize exposure\--including
    behaviors, personal protective equipment and personal hygiene
    practices.

6)  The procedures to be followed when changing ETO tanks. General safe
    work practices with all compressed gases.

7)  The expected behaviors in the event of an emergency-uncontrolled
    release of gas and personnel contamination.

# Program Evaluation

The program will be evaluated on an on-going basis and may be updated
and supplemented with additional information in keeping with subsequent
changes in the OSHA standard and accepted prudent practices. Evidence of
these changes will be maintained with the training materials.

#  {#section-8 .unnumbered}

#  {#section-9 .unnumbered}

#  {#section-10 .unnumbered}

# APPENDIX 4 {#appendix-4 .unnumbered}

# EMERGENCY PROCEDURES FOR ETHYLENE {#emergency-procedures-for-ethylene .unnumbered}

# OXIDE RELEASES {#oxide-releases .unnumbered}

Issuing Office: ORS/DOHS

**EMERGENCY PROCEDURES FOR ETHYLENE OXIDE (EtO) RELEASE**

**"ON-CAMPUS"**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**A. PURP0SE**

> The purpose of this document is to establish a written plan of action
> to follow in the event of an EtO release (leak/spill) in buildings
> occupied by NIH employees and others utilizing NIH facilities.

**B. REFERENCES**

1\. 29 CFR 1910.1047 - \"Ethylene Oxide Standard\"

2\. 29 CFR 1910.38 - \"Employee Emergency Plans and Fire

Prevention Plans\"

3\. NIH Policy Manual - 1430 NIH Occupant Evacuation Plan

**C. POLICY**

The Occupational Safety and Health Administration (OSHA) states that a
written plan for emergency situations shall be developed for each

workplace where there is a possibility of an emergency.

**D. EMERGENCY ACTION TO FOLLOW**

Steps to take in the event of an EtO release:

1.  If you become aware of, or suspect, an ethylene oxide release, alert
    all personnel in the room to the problem, leave the room
    immediately, and close all doors and windows as you leave in order
    to contain the gas as much as possible. Evacuate the immediate area.

2.  If EtO comes in contact with the skin or eyes, flush the area
    immediately with large amounts of water using the closest emergency
    shower or eye wash station.

3.  Once clear of the area, immediately use the nearest phone to report
    the release to the NIH Fire Department by calling 911. Be sure to
    provide the following information:

    a.  The exact location of the release, if known;

    b.  Whether or not there are any injured personnel;

    c.  Whether or not there is a risk of fire;

    d.  Your name, location and number from where you are calling.

4.  If Building evacuation is necessary, evacuate the area using the
    established routes outlined in NIH Policy Manual - 1430 NIH Occupant
    Evacuation Plan. (See attachment)

5.  Injured personnel will be transported to the nearest hospital, if
    necessary.

6.  Do not attempt to re-enter the area until the appropriate
    authorities determine the area is safe to enter.

> Issuing Office: ORS/DOHS
>
> EtO Facilities off Campus
>
> (Twinbrook II, Poolesville, and 5 Research Court)

**EMERGENCY PROCEDURES FOR ETHYLENE OXIDE (EtO) RELEASE**

**"OFF CAMPUS"**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**A. PURPOSE**

> The purpose of this document is to establish a written plan of action
> to follow in the event of an EtO release(leak/spill) in buildings
> occupied by NIH employees and others utilizing NIH facilities.

**B. REFERENCES**

1\. 29 CFR 1910.1047 - \"Ethylene Oxide Standard\"

2\. 29 CFR 1910.38 - \"Employee Emergency Plans and Fire

Prevention Plans\"

3\. NIH Policy Manual - 1430 NIH Occupant Evacuation Plan

**C. POLICY**

The Occupational Safety and Health Administration (OSHA) states that a

written plan for emergency situations shall be developed for each

workplace where there is a possibility of an emergency.

**D. EMERGENCY ACTION TO FOLLOW**

Steps to take in the event of an EtO release:

> 1\. If you become aware of, or suspect, an ethylene oxide release,
> alert all personnel in the room to the problem, leave the room
> immediately, and close all doors and windows as you leave in order to
> contain the gas as much as possible. Evacuate the immediate area.

2\. If EtO comes in contact with the skin or eyes, flush the area

immediately with large amounts of water using the closest emergency

shower or eye wash station.

3\. Once clear of the area, immediately use the nearest phone to report

the release to the Montgomery County Department of Fire and Rescue

Services by calling 9-911. Be sure to provide the following

information:

a\) the exact location of the release, if known;

b\) whether or not there are any injured personnel;

c\) whether or not there is a risk of fire;

d\) your name, location and number from where you are

calling.

4.  If building evacuation is necessary, evacuate the area using the

> established routes outlined in NIH Policy Manual - 1430 NIH Occupant
>
> Evacuation Plan. (see attachment)
>
> 5\. Injured personnel will be transported to the nearest hospital, if
>
> necessary.

6.  Do not attempt to re-enter the area until the appropriate
    authorities determine the area is safe to enter.