9/27/2018
`
`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
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`What's New | Offices OSHA
`
`Ethylene Oxide (EtO):
`Understanding OSHA's Exposure Monitoring Requirements
`Making the Right Dec/Signs -
`How to Comply with the Et0 Standard
`
`U.S. Department of Labor
`Occupational Safety and Health Administration
`OSHA 3325-01N
`2007
`
`Employers are responsible for providing a safe and healthful workplace for their employees. OSHA's role is to assure the safety and health of America's employees by setting
`and enforcing standards; providing training, outreach and education; establishing partnerships; and encouraging continual improvement in workplace safety and health.
`
`This handbook provides a general overview of a particular topic related to OSHA standards. It does not alter or determine compliance responsibilities in OSHA standards or the
`Occupational Safety and Health Act of 1970. Because interpretations and enforcement policy may change over time, you should consult current OSHA administrative
`interpretations and decisions by the Occupational Safety and Health Review Commission and the Courts for additional guidance on OSHA compliance requirements. This
`publication is in the public domain and may be reproduced, fully or partially, without permission. Source credit is requested but not required.
`
`This information is available to sensory impaired individuals upon request. Voice phone: (202) 693-1999; teletypewriter (
`
`Y) number: (877) 889-5627.
`
`Edwin G. Foulke, Jr.
`Assistant Secretary of Labor for
`Occupational Safety and Health
`
`Contents
`
`Purpose
`
`Background
`
`OSHA Requirement for Air Monitoring
`
`Clarifying the Different Types of Exposure Monitoring
`Personal Monitoring
`Area Monitoring
`Leak Detection
`
`The OSHA Exposure Levels
`
`Monitoring Requirements
`Initial Monitoring
`Periodic Monitoring
`Actions Triggered by Air Sample Results
`Methods of Detecting Emergency EtO Releases
`
`Emergency Situations
`Emergency Plan for EtO
`Emergency Alert Provision
`
`How to Get Help with Air Monitoring
`
`Additional Sources of Information
`
`References
`
`OSHA Assistance
`
`OSHA Regional Offices
`
`Purpose
`
`The purpose of this guidance document is to help employers understand how to monitor the quality of the air in workplaces where ethylene oxide (EtO) is processed, used, or
`handled. Air monitoring is an important activity that can help alert employers when unsafe levels of EtO are present in the air so that they can take steps to reduce employee
`exposure. EtO can be used more safely if appropriate precautions are taken and if equipment is adequately designed and maintained. This document:
`
`- Clarifies the different types of EtO exposure monitoring,
`
`https://www.osha.gov/Publications/ethylene_oxide.html
`
`1/10
`
`Regeneron Exhibit 1048.001
`
`
`
`

`

`9/27/2018
`
`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
`
`I Lists and explains the exposure levels used by OSHA,
`I Reviews the exposure monitoring requirements in OSHA's EtO rules, and
`I Outlines the monitoring decisions that the employer needs to make when employees work in areas where EtO is present.
`
`All of the required actions presented in this document are based on OSHA's EtO standard (29 CFR 1910.1047). This guidance document provides helpful suggestions for
`complying with §1910.1047 as well.
`
`This guidance document rs not a standard or regulatr'on, and it creates no new legal obligations. The guidance document rs advisory In nature, Infonnatr'onal in content, and
`is Intended to assist employers in provrdrng a safe and healb‘rful workplace. The Occupational Safety and Healb‘r Act requires employers to comply wrb‘r hazard-specific safety
`and healb‘r standards promulgated by OSI-M or by a State wib‘r an OSHA -approved State Plan. In addition, pursuant to Section 5(a)(1), the General Duty Clause of the Act;
`employers must provide their employees wib‘r a workplace free from recogn'ned hazards likely to cause death or serious physical harm. Employers can be cr'ted for violating
`fire General Duty Clause If there is a recogn'zed hazard and they no not take reasonable steps to prevent or abate the hazard. However, farlure to implement these
`
`recomme-rdations is not, In itself; a violation of the General Duty Clause. Citations can only be based on standards, regulations, and the General Duty Clause.
`
`Background
`
`EtO is used extensively by hospitals and other industries as a sterilizing agent. EtO is a colorless, odorless gas which is both flammable and highly reactive. Most importantly,
`you cannot smell EtO until it reaches levels that can cause serious harm to human health (NIOSH, 1989). Human and animal studies consistently show that EtO can be
`hazardous to human health. Short-term exposures to EtO can cause respiratory irritation and lung injury, shortness of breath, headache, nausea, vomiting, and diarrhea. Long-
`term exposure over many years may cause cancer, reproductive effects, genetic changes, and damage to the nervous system (Lamontagne et al., 1990).
`
`OSHA Requirement for Air Monitoring
`
`The OSHA EtO standard requires employers to conduct personal monitoring unless they are specifically exempt (see "Exemptions" text box at page 10). This guidance
`document is intended to help employers understand the difference between personal monitoring, area monitoring, and leak detection and why area monitoring is
`complementary to personal monitoring, but can never be used instead of it.
`
`Clarifying the Different Types of Exposure Monitoring
`
`There are three types of EtO monitoring available for determining levels of EtO in a workplace: 1) personal monitoring, 2) area monitoring, and 3) leak detection (a special
`type of area monitoring). However, personal monitoring is required to determine if there is compliance with the exposure limits of the standard.
`
`Personal Monitoring
`
`Personal monitoring involves measuring a person's exposure to EtO by testing the air that the person (an employee) would breathe regardless of where the person moves in
`the workplace. A sampling device is attached to the shirt collar or as close as practical to the nose and mouth of the employee in the employee's "breathing zone" - the
`hemisphere forward of the shoulders with a radius of approximately six to nine inches - to test airborne EtO concentrations.
`
`The device is worn for a specified period of time. During personal monitoring for EtO, the sample is collected for 15 minutes to test short-term exposure or for the length of a
`whole work shift (typically 8 hours; see the text box "What if the Work Shift is Not Exactly 8 Hours?" at page 8) to test for average exposures over the course of a workday.
`These air samples will be referred to here as 15-minute samples and 8-hour samples.
`
`Equipment used for personal monitoring typically includes a "passive diffusion monitor" (a type of clip-on tag that collects EtO), or alternatively a small air pump worn on the
`employee's belt that pulls a sample of air through a glass tube filled with a substance that captures EtO. These samples typically must be sent to a laboratory for analysis. 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.
`
`After the samples have been analyzed, the employer must post monitoring results within 15 days of receiving them, or notify employees of the results in writing. The employer
`must also mention the steps being taken to reduce employee exposures when the monitoring results indicate that the time-weighted average or excursion limit has been
`exceeded.
`
`Area Monitoring
`
`Area monitoring is used to show the levels of EtO throughout the general working area and to identify problems and priorities.
`
`Area samples should be taken close to a source of emission in order to evaluate concentrations or the effectiveness of steps taken to control exposure. Alternatively, area
`samples can be collected at various places in the working area to assess how far EtO might have spread. Equipment used for area monitoring is often mounted on the wall or
`placed directly on equipment. The monitoring instrumentation can be similar to that used for personal monitoring, or it can be of the "direct-reading" type, which gives an
`immediate reading of the EtO level. When an employer uses direct reading instruments, nothing needs to be sent to a laboratory but the equipment must be calibrated
`periodically to ensure accuracy.
`
`A wall-mounted emergency alert system used for area monitoring is one example of a direct-reading area monitor (also see subsection titled "Emergency Alert Provision" at
`page 18).
`Leak Detection
`
`Employers, who are required to create a written compliance program because their employees' exposures are over the permissible exposure limit, must also produce a
`schedule for routine leak detection surveys. Some businesses that use EtO find it helpful to test equipment such as sterilizers, pipes, tanks, and fittings at least every two
`weeks to confirm that there are no leaks. Portable EtO gas-detection meters are available to check for leaks around equipment such as sterilizers, tanks, fittings, and pipes that
`contain EtO. Leak testing is generally performed using hand-held EtO detection meters (a type of portable direct-reading instrument).
`
`The OSHA Exposure Levels
`
`The Federal OSHA regulation on EtO establishes certain allowable exposure levels. This section will explain the terms, units, and exposure levels that require action.
`
`Units of Measure: Exposure levels are reported as concentrations - the volume of EtO per volume of air. This is typically expressed as "parts per million" (also called "ppm").
`One part per million means that there is one part of EtO in every million parts of air sampled. Alternatively, the concentration of EtO can also be reported using metric units, in
`milligrams of EtO per cubic meter of air (mg/m3). It is important to compare only exposure values that have the same units of measure. For example, only compare exposure
`results reported as ppm to the OSHA levels for EtO reported in ppm.
`
`Action Level: The "action level" is the 8-hour exposure level that triggers certain actions under OSHA's EtO standard. If an employee's 8-hour sample result is
`equal to or greater than the action level, the employer must start certain required activities such as exposure monitoring and medical surveillance.
`The action level for EtO is 0.5 ppm (which equals 0.9 mg/m3).
`
`
`
`https://www.osha.gov/Publications/ethylene_oxide.html
`
`2/10
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`Regeneron Exhibit 1048.002
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`

`

`9/27/2018
`
`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
`
`Actions an employer must take if the personal monitoring test result is greater than, or equal to, the "action level" are outlined in the subsection titled "Actions Triggered by Air
`Sample Results" at page 15.
`
`Permis'ible Exposure Limit (PEL):This is the exposure level of EtO above which no employees may be exposed to under normal workplace conditions. You
`should become familiar with two PELs; one for 8-hour samples and one for 15-minute samples.
`
`Eight-Hour Time-Weighted Average (8-hour TWA) - This is an 8-hour (or full work shift) sample that represents the maximum average EtO
`levels that an employee should be exposed to.
`The 8-hour PEL for EtO is 1 ppm (which equals 1.8 mg/m3).
`
`Excursion Limit (15-minute) - This is a 15-minute (shortterm) sample that represents the maximum EtO exposure level that an employee may
`be exposed to for a short period of time.
`
`Rotating employees to different workstations so that they are not exposed to higher EtO levels is not an accepted way of meeting the 8-hour TWA
`or the Excursion Limit requirement.
`The 15-minute Excursion Limit for EtO is 5 ppm (equal to 9 mg/m3).
`
`Both types of samples are important because, taken together, they help employers protect employees over the range of exposure conditions that employees are likely to
`experience. Actions that an employer must take if these PELs are exceeded are outlined in Tables 3 and 4 at pages 15-17.
`
`What if the Walk Shift is Not Exactly 8 Hams?
`When you collect an 8-hour sample, OSHA expects you to collect the sample for the length of the whole work shift, no matter how long it is. The shift might be more or less
`than 8 hours. Although not every sample will be exactly 8 hours, the OSHA action level and 8-hour permissible exposure limit must only be compared to an 8-hour sample
`result.
`
`To avoid confusion caused by samples collected for more or less time, OSHA allows you to use a simple equation that converts any full-shift sample result to an 8-hour
`equivalent result(also called an 8-hour time-weighted average or an 8- hour TWA result).
`
`employee. In this case, ask the laboratory to combine all the results from one employee to create a single 8-hour TWA result.
`
`
`
`TA = The actual time during which your sample was collected (in minutes).
`CA = The actual result (concentration) for your sample (in ppm).
`T8 = 480 minutes (this is the number of minutes in 8 hours).
`C8 = The 8-hour equivalent result for your sample (in ppm).
`
`Equation:
`C8 = CA(TA)/T8
`
`Fortunately, most analytical laboratories will do the calculation for you. Ask the laboratory to "Report the full-shift results as 8-hour time-weighted averages (or 8-hour
`TWAs)." You do not need to make this arrangement for 15-minute samples, which should always be collected for exactly 15 minutes.
`
`When exposure levels are high, it may be necessary to collect a series of mid-length samples (for example, 1-2 hours each) instead of a single 8-hour sample for an
`
`
`
`Monitoring Requirements
`
`0 What types of monitoring are required to be in compliance with OSHA's EtO standard?
`The OSHA EtO standard requires that each employer whose workplace does not meet the "exemption" clause, §1910.1047(a)(2), must perform personal monitoring to show
`whether EtO exposures are exceeding the 8-hour and/or the 15- minute PEL. The OSHA standard requires that these samples be "representative" of EtO exposures (see
`"Criteria for Using Results from Similar Work Conditions" text box, at page 11). There are two types of monitoring requirements: I'nit'I'a/and periodic.
`
`Initial Monitoring
`
`0 Do I need to collect initial EtO samples?
`Yes. If you are not exempt (see "Exemptions" text box at page 10) and there is reason to believe that exposure levels may equal or be above the action level under "expected
`conditions of operation," then you are required to conduct personal EtO monitoring to accurately measure the airborne concentrations of EtO. Most employers should assume
`that exposure levels may reach or exceed the action level and that they must conduct exposure monitoring: 1) if their business involves processing, using, or handling products
`containing EtO; 2) if they are not exempt as described in the Exemption text box; and 3) if they have never conducted personal monitoring.
`
`This level of caution is important because accidental releases of EtO may occur from several sources, including leaking cartridges, sterilizer discharge lines and leaks, or routine
`changing of EtO supply cylinders. A relatively small quantity of EtO released into an average office-sized space can result in concentrations that are many times above the
`action level or PEL (NIOSH, 1989; Lamontagne and Kelsey 1998). If there are special circumstances that would suggest that monitoring is not required for your workplace and
`you need further clarification, we encourage you to contact your local area OSHA office. Locate your local area OSHA office by phone at 1-800-321-OSHA or online at
`h_ttp:[[www.osha.gov[html[RAmap.html.
`
`When carrying out initial monitoring, you must collect both 8- hour samples (full work shift) and 15-minute samples (short-term). At least one sample of each type is
`required for:
`
`I Each work shift,
`I Each job classification, and
`
`I In each work area of the workplace.
`
`Exemptions
`
`Is Monitoring Always Required?
`No. An employer is exempt from the standard and, therefore, is not required to conduct employee exposure monitoring if "objective data" demonstrates the processing, use,
`or handling of products containing EtO are not capable of releasing EtO in concentrations at or above the OSHA action level or in excess of the excursion limit under
`expected conditions that will cause the greatest possible release.
`
`The objective data might include specific information generated by an individual employer or obtained from chemical manufacturers, industry studies, or trade associations
`that documents why your facility's processing, use, or handling of EtO would not result in workplace concentrations exceeding the action level or excursion limit.
`
`https://www.osha.gov/Publications/ethylene_oxide.html
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`3/10
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`Regeneron Exhibit 1048.003
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`9/27/2018
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`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
`
`Objective data records mustbe kept as long as the employer relies on the data to demonstrate that monitoring is not required. The types of information that should be kept
`include:
`
`I The source of the objective data,
`I The testing protocol, results, and/or analysis of data,
`I The exempted operation and corresponding information supporting the exemption, and
`I Any other data relevant to the operations, materials, processes, or employee exposures covered by the exemption.
`
`
`0 Do I need to collect initial personal monitoring samples for every single employee, on every work shift?
`No. But you do need to determine the exposure level of every employee. If you have only one employee, orjust a few who all do differentjobs, you need to collect personal
`samples for each employee. However, if you have two or more employees who do the same job, you may be able to collect personal samples for one of these employees and
`use the results to document exposure levels for all of these employees. This is known as representative sampling. To decide whether the results for one employee will
`represent the EtO exposure of other employees in the group, you must evaluate certain criteria (see "Criteria for Using Results from Similar Work Conditions" text box).
`
`If the answer is "no" to any of the questions, you probably need to compare a smaller and more similar group of employees, or conduct individual personal monitoring for each
`employee. If the answer to all of these questions is "yes," you may use the results from one or more employee to represent the exposure of other employees in the group.
`However, you must select the employee who is likely to have the highest EtO exposure (due to slight variations in work area, work practices, or experience).
`
`Criteria for Using Results from Similar Work Conditions
`
`Do the employees do the same work?
`Are their working conditions similar (for example, do the employees use similar equipment and EtO products?)
`Do the employees have similar work practices, with similar EtO control measures?
`Do they work in the same area or in areas with similar air movement patterns?
`Do the employees use the same EtO product for the same amount of time during their shifts?
`
`Do the employees work the same distance from possible sources of EtO?
`
`You must also keep a record stating your reasons for selecting an employee from one work shift to represent employees on another shift. One way to document the similarity
`of shifts is by sampling employees on each shift one time to show that the employee exposures are the same on each shift. If the exposures are the same, you can conduct
`future required periodic sampling on a single shift and consider it representative of all shifts. You may use this option with 8-hour samples and with 15-minute samples.
`
`- Am I permitted to use results of air samples collected at another time or at a different location from my initial monitoring results?
`Yes, but the work conditions must have been similar on the two dates, or at the two locations. The text box "Criteria for Using Results from Similar Work Conditions" also
`applies in this situation. Again, if the answer is "no" to one or more of the questions, it is likely that you must conduct initial monitoring. If the answer is "yes," then OSHA
`allows you to meet the initial monitoring requirements by using personal monitoring results collected for other employees at an earlier date or at a different location in the
`workplace. Be sure to keep a document explaining why it was appropriate to use those results.
`
`- Which 15-minute period should I monitor?
`You must collect a 15-minute air sample during the portion of the work shift when you think that the employee's EtO exposure will be the highest. You may need to collect
`several 15-minute samples during the same shift (see text box "Why Is It So Important to Collect15-Minute Samples?").
`
`Why Is It So Important to Collect 15-Minute Samples?
`
`Research suggests that EtO exposures above the 15-minute OSHA PEL continue to occur in workplaces that are involved in processing, using, or handling products
`containing EtO. Recent studies have also shown that personal monitoring activities often fail to detect accidental exposures during EtO leaks and spills (Lamontagne et al.,
`2004; Lamontagne and Kelsey 1998). Therefore, it is important to carefully consider the types of activities for which 15-minute monitoring are most useful. The following
`examples should provide some guidance:
`
`I A common situation in which accidental exposures to EtO might occur involves changing EtO supply cylinders. Consider collecting 15-minute personal samples while
`the employees being sampled are replacing EtO cylinders.
`I Employees who work directly with, or in close proximity to, EtO sterilizers or similar equipment should be monitored frequently for short-term (i.e., 15-minute)
`exposures to EtO at the times when they are most likely to experience exposure (such as when the employee opens the door at the end of the cycle, or while EtO is
`
`being pumped in or out of the equipment).
`
`Periodic Monitoring
`
`0 Do I need to repeat the EtO personal monitoring and, if so, what is the monitoring schedule?
`The answer depends on the results of initial personal monitoring for EtO. Under certain situations, a long-term schedule for personal monitoring for EtO must be established.
`Tables 1 and 2 provide the "periodic monitoring" schedule required by the EtO standard. The personal monitoring results might also trigger other requirements that are listed
`in Tables 3 and 4, which appear later in this guidance document.
`
`Table 1 - Schedule for OSHA Exposure Monitoring
`
`‘ If your initial employee monitoring results...
`...show that employee exposure is below the 8-
`hour action level,
`
`Discontinue monitoring for only those employees
`whose exposures are represented by the initial
`monitoring.
`
`Table 2 - Requirements for Discontinuing Monitoring
`
`
`
`Conduct additional 8-hour personal exposure
`...are between the 8-hour action level (0.5 ppm)
`and the 8-hour permissible exposure limit (PEL) of monitoring at least every 6 months.
`1 ppm (including the value 0.5 ppm),
`
`...are above the 8-hour PEL of 1 ppm or above the
`15-minute PEL of 5 ppm,
`
`Conduct additional personal exposure monitoring
`(either 8-hour or 15-minute, depending on the
`sample type that initially exceeded the limit) at
`least every 3 months.
`
`If your periodic employee monitoring results Then...
`had been above the PEL (either the 8-hour
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`https://www.osha.gov/Publications/ethylene_oxide.html
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`4/10
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`Regeneron Exhibit 1048.004
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`9/27/2018
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`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
`
`TWA or the 15-minute excursion limit) and...
`...are now between the 8-hour action level (0.5
`ppm) and the 8-hour PEL of 1 ppm (including the
`value 0.5 ppm) for two consecutive tests (these
`samples must be collected at least 7 days apart,
`but no more than 3 months apart),
`
`...are now less than the 8-hour action level (0.5
`ppm) for two consecutive tests (the samples must
`be collected at least 7 days apart, but no more
`than 3 months apart),
`...now indicate that employee exposures are at or
`below the 15-minute PEL of 5 ppm (the excursion
`limit) for two consecutive tests (the samples must
`be collected at least 7 days apart, but no more
`than 3
`months apart),
`For definitions of OSHA Exposure Levels, see page 6.
`
`
`
`You can decrease the 8-hour personal monitoring
`frequency from every 3 months to every 6 months.
`Note: if 15-minute exposures exceed the excursion
`limit of 5 ppm, you will still need to conduct the
`15-minute (excursion limit) monitoring at least
`every 3 months.
`You are no longer required to conduct periodic
`personal monitoring unless a change in the
`workplace makes additional monitoring necessary.
`
`You may discontinue 15-minute (excursion limit)
`monitoring for those employees whose exposures
`are represented by the initial monitoring.
`
`0 When must I resume air monitoring?
`
`You must start monitoring again whenever there is a change that may result in new or additional exposures to EtO. Examples of changes that should be evaluated to
`determine if they may result in new or additional exposures and, therefore, would trigger resuming EtO sampling include:
`
`Changing EtO process equipment or increasing the volume of EtO used,
`Modifying the exhaust ventilation system,
`Hiring new or inexperienced employees, and
`Changing work practices.
`
`You also must resume sampling any time that you have a reason to suspect that such a change may result in new or additional exposures.
`
`Actions Triggered by Air Sample Results
`
`0 I received air sampling results; now what do I do?
`Tables 3 and 4 provide the lists of actions you need to take as a result of EtO monitoring results that exceed specific levels. These actions are based on the OSHA action level
`and/or PELs (8-hour and/or 15-minute samples).
`
`Result
`interpretation:
`
`Table 3 - Actions Triggered by Air Sample Results
`Other OSHA
`8-hour sample is 8-hour sample is 15-minute
`equal to or above above
`sample is above Standards that
`Action Level
`Permissible Level Excursion Limit Apply**
`
`detection
`
`
`
`5/10
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`Regeneron Exhibit 1048.005
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`0.5 ppm or greater Above 1 ppm
`Result value:
`Action Triggered by Monitoring Results
`Provide medical
`surveillance (if
`employee's
`exposure is more
`than 30 days per
`year)*
`Provide information Yes
`and training
`
`Yes
`
`Establish a
`regulated area
`
`Not required
`
`Yes
`
`Above 5 ppm —
`
`Net requred
`
`19101020
`
`Yes
`
`Yes, also if
`expectedto exceed
`this level
`
`Take steps to
`reduce exposure
`levels with
`engineering
`controls or other
`methods
`
`Develop and put
`into action a
`written compliance
`program for
`reducing exposure
`and establishing a
`schedule for
`periodic leak
`
`Netrequred ..-
`NOtrequred ll.
`
`Provide respirators Not required __ 1910. 134
`Ensure that caution Yes
`1910. 1200
`labels are fixed to
`containers (also
`when container
`contents are
`capable of causing
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`https://www.osha.gov/Publications/ethylene_oxide.html
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`9/27/2018
`or can be
`reasonably
`foreseen to cause
`these exposure
`levels)
`Establish periodic
`air monitoring
`programs
`
`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
`
`Yes, at least every Yes, at least every Yes, at least every
`
`1910.1020
`
`
`
`* Medical examinations are also required if there is an exposure related to an emergency situation.
`** For information on OSHA standards that apply, see the text box titled "Important References to
`OSHA Standards".
`
`Table 4 - Actions Triggered by the Air Sampling Process
`
`Other Actlo_ns TrIggered by When to Take Action
`AIr Monltorlng
`
`Other OSHA Standards that
`Apply*
`
`Post monitoring results within 15 Any time that samples are
`days of receiving them, or give
`collected - regardless of the
`employees the written results.
`results
`Mention steps being taken to
`reduce exposures.
`
`Maintain records of monitoring
`for 30 years
`
`Allow employees or their
`representatives to observe air
`monitoring
`
`Any time that samples are
`collected - regardless of the
`results
`
`Any time that samples are
`collected
`
`1910.1020
`
`1910.1020
`
`* For information on OSHA standards that apply, see the text box titled "Important References to OSHA
`Standards" at page 22.
`
`
`
`Methods of Detecting Emergency EtO Releases
`
`There are a number of options available on how to monitor and test for emergency leaks of EtO. These methods may be appropriate in addition to, but not instead of, personal
`air monitoring. They cannot be used as a substitute for personal monitoring to satisfy OSHA personal air monitoring requirements.
`
`Emergency Situations
`
`The OSHA EtO standard requires that a written plan for each workplace be developed for emergency situations. (See also §1910.38 Emergency Action Plans and §1910.39 Fire
`Prevention Plans.)
`
`Emergency Plan for Etc
`The following are some simple steps to ensure that your workplace meets the emergency plan requirements in OSHA's EtO standard:
`
`I For employers with more than 10 employees, the emergency plan must be in writing and available to employees. If you have 10 or fewer employees, the plan may be
`communicated verbally to employees.
`I The plan must include procedures for emergency evacuation, including type of evacuation and exit route assignments (refer to OSHA's standard for "Emergency Action
`Plans", listed in the text box on Important References to OSHA Standards at page 22). Although not specifically required, you can be proactive in emergency planning
`preparations by conducting employee evacuation drills for potential EtO emergencies.
`- You must have a system for alerting employees to emergency EtO exposures. You do have the flexibility to choose any effective method of alerting employees to
`potential EtO releases that could result in harmful exposures.
`- The plan must specifically provide that employees engaged in correcting emergency conditions shall be equipped with respiratory protection as required by
`§1910.1047(g) until the emergency is abated and must be implemented in accordance with §1910.134, Respiratory Protection.
`
`Emergency Alert Provision
`The emergency alert provision of OSHA's EtO standard allows employers to choose the most effective method of alerting employees across industries. As part of the
`emergency plan, you must develop a system for alerting your employees. The precise type of alert system is not specified in the OSHA EtO standard.
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`OSHA considers the following alert methods acceptable for an EtO monitoring system:
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`- A bell or alfrer alarm 5ystem:A bell or alarm system must have a distinctive signal to alert employees to an EtO leak (refer to §1910.165, Employee Alarm Systems).
`- A Voice-activatajsystem: Like other alarm types, this system must have a distinctive signal to alert employees to an EtO leak.
`- Voice communications: For those employers with 10 or fewer employees in a particular workplace, the requirements under
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`Alarm systems basically function as a monitor to test the surrounding air for EtO levels.
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`To monitor EtO levels near sterilizers, some employers find it convenient to install a wall-mounted, or equipment-mounted system.
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`Monitoring Systems
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`More information about some specific types of monitoring devices can be found at page 20 under "Additional Sources of Information".
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`Commercially available alarms that monitor EtO levels and use both visual and sound alarms can alert employees in noisy or crowded areas when the level of EtO is higher
`than it should be.
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`"Employee alarm systems" states that direct voice communication is an acceptable method of alerting employees, providing that all employees at their respective workstations
`can clearly hear the person's voice. For workplaces with more than 10 employees, simple voice communication is not acceptable.
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`0 Is there a specific EtO level that I should use to trigger an alert?
`OSHA has not established an "alert" level; you should choose an alert trigger level that is appropriate for your workplace. When evaluating alarms, it is important to remember
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`https://www.osha.gov/Publications/ethylene_oxide.html
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`6/1 0
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`Regeneron Exhibit 1048.006
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`9/27/2018
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`Ethylene Oxide (EtO) Understanding OSHA's Exposure Monitoring Requirements
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`that the alarm's purpose is to alert employees to unintended and hazardous EtO releases, rather than to average concentrations measured over an 8-hour work shift. It is not
`necessary to base the EtO alarm trigger specifically on the OSHA action level (0.5 ppm) or permissible exposure limits for 8 hours (1 ppm) or 15 minutes (5 ppm).
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`You should also be aware that there is a large range in the cost and sensitivity of commercially available monitors. Some systems alert employees to EtO levels