Occupational Safety and Health Act of 1970

Occupatioal Safety ad Health Act of 1970 To assure safe ad healthful workig coditios for workig me ad wome; by authorizig eforcemet of the stadards developed uder the Act; by assistig ad ecouragig the States i their efforts to assure safe ad healthful workig coditios; by providig for research, iformatio, educatio, ad traiig i the field of occupatioal safety ad health. This guidace documet is ot a stadard or regulatio, ad it creates o ew legal obligatios. The guidace documet is advisory i ature, is iformatioal i cotet, ad is iteded to assist employers i providig a safe ad healthy workplace. The Occupatioal Safety ad Health Act requires employers to comply with safety ad health stadards promulgated by OSHA or by a State with a OSHA-approved state pla. However, the Ethylee Oxide stadard (29 CFR 1910.1047) is madatory for employers ad to the extet that this guidace documet restates the stadard, those restatemets are madatory. I additio, pursuat to Sectio 5(a)(1), the Geeral Duty Clause of the Act, employers must provide their employees with a workplace free from recogized hazards likely to cause death or serious physical harm. Citatios ca oly be based o stadards, regulatios, ad the Geeral Duty Clause. Sectio 1

Small Busiess Guide for Ethylee Oxide U.S. Departmet of Labor Occupatioal Safety ad Health Admiistratio OSHA 3359-04 2009

Cotets Cover photos: Getty Images, Washigto State OSHA, Natioal Istitute for Occupatioal Safety ad Health (NIOSH) 1. Overview... 3 2. Exposure Moitorig... 4 A. Uderstadig OSHA s EtO Exposure Moitorig Requiremets... 4 i. Differet Types of Exposure Moitorig... 4 ii. OSHA Requiremet for Air Moitorig... 4 a. Persoal Moitorig... 5 b. Area Moitorig... 6 c. Leak Detectio... 6 iii. OSHA Exposure Levels... 7 a. Permissible Exposure Limits... 7 B. Moitorig Requiremets... 8 i. Iitial Moitorig... 9 ii. Periodic Moitorig... 12 C. Actios Triggered by Air Sample Results... 14 D. How to Get Help with Air Moitorig... 17 3. Exposure Reductio/Prevetio... 18 A. Methods of Detectig Emergecy EtO Releases... 18 i. Emergecy Situatios... 18 ii. Emergecy Pla for EtO... 18 iii. Emergecy Alert Provisio... 19 B. Develop a Compliace Program... 21 C. Reduce Exposures with Egieerig Cotrols or Other Methods... 22 D. Provide Respiratory Protectio... 23 4. Other Requiremets... 24 A. Employee Iformatio ad Traiig... 24 i. Hazard Commuicatio... 24 ii. Establish Regulated Areas... 25 iii. Esure that Cautioary Labels are Fixed to Cotaiers... 26 iv. MSDS... 27 B. Medical Surveillace... 27 1

5. Additioal Compliace Details ad Helpful Iformatio... 31 A. Retai the Required Exposure Moitorig Records... 31 B. Accuracy of Samplig ad Aalytical Methods... 32 C. Exemptios from Iitial Moitorig... 33 D. Work Shifts of Other Tha 8 Hours... 34 E. How to Obtai Further Assistace... 35 i. Work with Idustry ad Supplier Represetatives... 35 ii. Locate a Idustrial Hygiee Cosultat... 35 iii. Fid a Aalytical Laboratory... 36 F. How to Fid a Healthcare Provider for Your Medical Surveillace Program... 37 G. What a Medical Exam Must Iclude... 38 H. Accessig OSHA Stadards o the Iteret... 39 I. Other Names for Ethylee Oxide... 40 J. Breathig Zoe... 41 K. Passive Diffusio Dosimeter (or Moitor)... 42 L. Air Samplig Pump ad Sorbet Tube... 47 M. Compariso of Passive Dosimeters ad Traditioal Air Samplig Methods Usig a Pump ad Sorbet Tube... 59 6. Related OSHA Stadards ad Other Helpful Resources... 61 A. Ethylee Oxide - Geeral... 61 B. Coductig Persoal Moitorig... 62 C. Respiratory Protectio ad Persoal Protective Equipmet... 68 D. Exposure Cotrol... 69 E. Hazard Commuicatio... 70 F. Work Practices... 72 G. Medical Moitorig... 73 H. Emergecy Plaig ad Alert Systems... 74 I. Geeral Occupatioal Safety ad Health Maagemet for Small Busiesses... 76 7. Refereces... 77 8. OSHA Assistace... 78 9. OSHA Regioal Offices... 81 2

1. Overview Ethylee oxide (EtO) is used extesively by hospitals ad other idustries as a sterilizig aget. EtO is a colorless, odorless gas, which is both flammable ad highly reactive. Most importatly, you caot smell EtO util it reaches levels that ca cause serious harm to huma health (NIOSH, 1989). Huma ad aimal studies cosistetly show that EtO ca be hazardous to huma health. Short-term exposures to EtO ca cause respiratory irritatio ad lug ijury, shortess of breath, headache, ausea, vomitig, ad diarrhea. Log-term exposure over may years may cause cacer, reproductive effects, geetic chages, ad damage to the ervous system (LaMotage et al., 1990). The purpose of this guidace documet is to help employers uderstad the EtO stadard, with particular emphasis o how to moitor the quality of the air i workplaces where EtO is processed, used, or hadled. Air moitorig is a importat activity that ca help alert employers whe usafe levels of EtO are preset i the air so they ca take steps to reduce employee exposure. EtO ca be used more safely if appropriate precautios are take ad if equipmet is adequately desiged ad maitaied. This documet: Clarifies the differet types of EtO exposure moitorig. Reviews the exposure moitorig requiremets i OSHA s EtO stadard. Lists ad explais the exposure levels used by OSHA. Provides a overview of actios required whe moitorig shows that employees are exposed to EtO at levels exceedig the allowable limits. Outlies the moitorig decisios you eed to make whe employees work i areas where EtO is preset. All of the required actios preseted i this documet are based o OSHA s EtO stadard (29 CFR 1910.1047). This guidace documet provides helpful suggestios for complyig with the EtO stadard. You will fid other geeral sources of iformatio o EtO listed i Sectio 6 - Related OSHA Stadards ad Other Helpful Resources. To see a list of other terms sometimes used for EtO, see Sectio 5.I - Other Names for Ethylee Oxide. 3 Sectio 1

2. Exposure Moitorig A. Uderstadig OSHA s EtO Exposure Moitorig Requiremets i. Differet Types of Exposure Moitorig There are three types of EtO moitorig available for determiig levels of EtO i a workplace: 1) persoal moitorig, 2) area moitorig, ad 3) leak detectio (a special type of area moitorig). However, persoal moitorig is required to determie if there is compliace with the exposure limits of the stadard. ii. OSHA Requiremet for Air Moitorig The OSHA EtO stadard requires employers who have EtO preset i their workplace to coduct persoal moitorig uless they are specifically exempt from the requiremet. This guidace documet is iteded to help employers uderstad the differece betwee persoal moitorig, area moitorig, ad leak detectio, ad why area moitorig is complemetary to persoal moitorig, but ca ever be used istead of it. Idicates lik to more iformatio elsewhere i this documet. Sectio 2 4

Passive Dosimeter for persoal exposure moitorig Employee wearig a passive diffusio moitor (or dosimeter). For more iformatio, see Sectio 5.K - Passive Diffusio Dosimeter. a. Persoal Moitorig Persoal moitorig ivolves measurig a perso s exposure to EtO by testig the air that the perso (a employee) would breathe regardless of where the perso moves i the workplace. To test airbore EtO cocetratios, a samplig device is attached to the shirt collar or as close as practical to the ose ad mouth of the employee. This is cosidered the employee s breathig zoe. See Sectio 5.J - Breathig Zoe. The device is wor for a specified period of time. Durig persoal moitorig for EtO, the sample is collected for 15 miutes to test for short-term exposures (the excursio limit) or for the legth of a whole work shift (typically 8 hours) to test for average exposures over the course of a workday (time weighted average or TWA). These air samples will be referred to here as 15-miute samples ad 8-hour samples. Equipmet used for persoal moitorig typically icludes a passive diffusio moitor (a type of clip-o tag that collects EtO) or, alteratively, a small air pump wor o the employee s belt that pulls a sample of air through a glass tube (called a sorbet tube) filled with a substace that captures EtO. These samples typically must be set to a laboratory for aalysis. Care must be used i collectig the sample ad moitorig it to esure a accurate measuremet. See Sectio 5.M - Compariso of Passive Dosimeters ad Traditioal Air Samplig Methods Usig a Pump ad Sorbet Tube. Employee wearig a air samplig pump ad sorbet tube. For more iformatio, see Sectio 5.L Air Samplig Pump ad Sorbet Tube. Withi 15 days after receivig the results of the moitorig from the laboratory, the employer must otify each affected employee of these results. This may be doe by postig the results i a appropriate locatio, accessible to the employee (social security umbers should ot be posted), or by providig the results to the employee idividually ad i writig. If a employer uses represetative samplig (see sectio 2.B.i), the each employee represeted by the sample should be otified of the result. 5 Sectio 2

A remote display of a EtO moitorig system. Itersca Corp b. Area Moitorig Area moitorig is used to show the levels of EtO throughout the geeral work area ad to idetify problems ad priorities, but this kid of moitorig is ot required by the EtO stadard. Area samples should be take close to a source of emissio i order to evaluate cocetratios or the effectiveess of steps beig take to cotrol exposure. Alteratively, area samples ca be collected at various places i the work area to assess how far EtO might have spread. Istrumets used for area moitorig are ofte mouted o the wall or placed directly o equipmet. The moitorig istrumetatio ca be similar to that used for persoal moitorig, or it ca be of the direct-readig type, which gives a immediate readig of the EtO level. Whe a employer uses direct readig istrumets, othig eeds to be set to a laboratory, but the equipmet must be calibrated periodically to esure accuracy. A wall-mouted emergecy alert system used for area moitorig is oe example of a direct-readig area moitorig istrumet. c. Leak Detectio Employers who are required to create a writte compliace program because their employees exposures are over the permissible exposure limit must also produce a schedule for routie leak detectio surveys. Some busiesses that use EtO fid it helpful to test equipmet such as sterilizers, pipes, taks, ad fittigs at least every two weeks to cofirm that there are o leaks. Portable EtO gas-detectio meters are available to check for leaks aroud equipmet such as sterilizers, taks, fittigs ad pipes that cotai EtO. Leak testig is geerally performed usig had-held EtO detectio meters (a type of portable direct-readig istrumet). See the related Sectio 3.A.iii - Emergecy Alert Provisio. 6

iii. OSHA Exposure Levels The Federal OSHA EtO stadard establishes certai allowable exposure levels. This sectio will explai the terms, uits, ad exposure levels that require actio. Uits of Measure: Exposure levels are reported as cocetratios the volume of EtO per volume of air. This is typically expressed as parts per millio (also called ppm ). Oe part per millio meas that there is oe part of EtO i every millio parts of air sampled. Alteratively, the cocetratio of EtO ca also be reported usig weight of EtO per volume of air milligrams of EtO per cubic meter of air (mg/m 3 ). It is importat to compare oly exposure values that have the same uits of measure. For example, oly compare exposure results reported i the uits ppm to the OSHA levels for EtO provided i ppm. The actio level for EtO is 0.5 ppm (which equals 0.9 mg/m 3 ) a. Permissible Exposure Limits Actio Level: The actio level is the 8-hour exposure level that triggers certai actios uder OSHA s EtO stadard. If a employee s 8-hour sample result is equal to or greater tha the actio level, the employer must start certai required activities such as exposure moitorig ad medical surveillace. The actio level for EtO is 0.5 ppm (which equals 0.9 mg/m 3 ). Actios a employer must take if the persoal moitorig test result is greater tha, or equal to, the actio level are outlied i Sectio 2.C - Actios Triggered by Air Sample Results. Permissible Exposure Limit (PEL): This is the exposure level of EtO above which o employees may be exposed uder ormal workplace coditios. You should become familiar with two EtO PELs, oe for 8-hour samples ad oe for 15-miute samples. 7 Sectio 2

The 8-hour PEL for EtO is 1 ppm (which equals 1.8 mg/m 3 ) Eight-Hour Time-Weighted Average (8-hour TWA) This is a 8-hour (or full work shift) sample that represets the maximum average EtO level to which a employee may be exposed. The 8-hour PEL for EtO is 1 ppm (which equals 1.8 mg/m 3 ). Excursio Limit (15-miute) This is a 15-miute (short-term) sample that represets the maximum EtO exposure level to which a employee may be exposed to for a short period of time. The 15-miute excursio limit for EtO is 5 ppm (equal to 9 mg/m 3 ). The 15-miute excursio limit for EtO is 5 ppm (equal to 9 mg/m 3 ) Rotatig employees to differet workstatios so that they are ot exposed to higher EtO levels is ot a acceptable way of meetig the 8-hour TWA or the Excursio Limit requiremet. Both types of samples are importat because, take together, they help employers protect employees over the rage of exposure coditios that employees are likely to experiece. Actios a employer must take if these PELs are exceeded are outlied i Sectio 2.C - Actios Triggered by Air Sample Results. What if the work shift is ot exactly 8 hours? If the shift is more or less tha 8 hours, see Sectio 5.D - Work Shifts of Not Exactly 8 Hours B. Moitorig Requiremets The OSHA EtO stadard requires that each employer with EtO preset, whose workplace does ot meet the exemptio clause (1910.1047(a)(2)), to perform persoal moitorig to show whether EtO exposures are exceedig the 8-hour ad/or the 15-miute PEL. The OSHA stadard requires that these samples be represetative of EtO exposures uder the typical workplace coditios. There are two types of moitorig requiremets: iitial ad periodic. Sectio 2 8

i. Iitial Moitorig Do I eed to collect iitial EtO samples? Yes. If you have EtO preset i the workplace you are required to coduct persoal EtO moitorig of employees who might be exposed to EtO to accurately measure the airbore cocetratios of EtO. Most employers should assume that they must coduct exposure moitorig: 1) if their busiess ivolves processig, usig, or hadlig products cotaiig EtO, 2) if they are ot exempt as described i Sectio 5.C - Exemptios from Iitial Moitorig, ad 3) if they have ever coducted persoal moitorig. s-detectio meters check for leaks et such as steriltigs ad pipes that ak testig This level of cautio is importat because accidetal releases of EtO may occur from several sources, icludig leakig cartridges, sterilizer discharge lies, ad leaks or routie chagig of EtO supply cyliders. A relatively small quatity of EtO released ito a average-sized office space ca result i cocetratios that are may times the actio level or PEL (NIOSH, 1989; LaMotage ad Kelsey 1998). If there are special circumstaces that would suggest moitorig is ot required for your workplace ad you eed further clarificatio, we ecourage you to cotact your local area OSHA office by callig 1-800-321-OSHA or visitig www.osha.gov/html/ramap.html. Whe carryig out iitial moitorig, you must collect both 8-hour samples (full work shift) ad 15-miute samples (short-term). At least oe sample of each type is required for: Ethylee oxide pipe leak i joit. Each work shift, Each job classificatio, ad Each work area of the workplace. 9 Sectio 2

Daily Staffig Day Shift Supply Techicia (Level 1) Supply Techicia (Level 2) Jaitor Housekeeper Maiteace Operator Receivig Dock Maager Eveig Shift Supply Techicia (Level 1) Supply Techicia (Level 2) Jaitor Night Shift Supply Techicia (Level 2) Housekeeper Questio: At your workplace, do all supply techicias have the same level of EtO exposure? What about jaitors? Aswer: The employees exposure to EtO will ot be the same if their tasks are differet or if they work with EtO for a differet legth of time tha other employees. Sectio 2 10 Do I eed to collect iitial persoal moitorig samples for every employee, o every work shift? No. But you do eed to determie the exposure level of every employee. If you have oly oe employee, or just a few who all do differet jobs, you eed to collect persoal samples for each employee. If you have two or more employees who do the same job, however, you may be able to collect persoal samples for oe of these employees ad use the results to documet exposure levels for all of these employees. This is kow as represetative samplig. To decide whether the results for oe employee will represet the EtO exposure of other employees i the group, you must evaluate certai criteria: Criteria for Usig Results from Similar Work Coditios Do the employees do the same work? Are their workig coditios similar (e.g., do the employees use similar equipmet ad EtO products)? Do the employees have similar work practices, with similar EtO cotrol measures? Do they work i the same area or i areas with similar air movemet patters? Do the employees use the same EtO product for the same amout of time durig their shifts? Do the employees work the same distace from possible sources of EtO? If the aswer is o to ay of the questios above, you may ot use oe perso s results to represet the EtO exposure of other employees. Istead you eed to idetify a smaller group of employees that have all of these criteria i commo. Alteratively, you ca coduct idividual persoal moitorig for each employee. If the aswer to all of the above questios is yes, you may use the results from oe or more employee(s) to represet the exposure of other employees i the group. You must, however, select the employee who is likely to have the highest EtO exposure (due to slight variatios i work area, work practices, or experiece) as the employee whose EtO exposure will represet that of the other employees i the group.

Day Shift 7:00 Sig i 7:05 Atted traiig Today s Schedule 7:45 Chage sterilizer gas cylider 8:05 Paperwork 9:30 Break 9:45 Meet with Jose M. 10:15 Delivery due/ivetory 11:30 Luch 12:00 Remove batch from sterilizer #3 12:15 Paperwork 12:30 Sterilizer duty 2:00 Break 2:15 Sterilizer duty 3:30 Sig out Questio: Whe should 15-miute samples be collected? Aswer: Collect a 15-miute sample for 15 of the 20 miutes betwee 7:45 ad 8:05. Aother sample should be collected at 12:00. It might also be ecessary to collect a additioal 15-miute sample durig the afteroo sterilizer duty, for example whe the employee is pumpig EtO out of the equipmet. You must also keep a record statig your reasos for selectig a employee from oe work shift to represet employees o aother shift. Oe way to documet the similarity of shifts is by samplig employees o each shift oe time to show that the employee exposures are the same o each shift. If the exposures are the same, you ca coduct required periodic samplig i the future o a sigle shift ad cosider it represetative of all shifts. You may use this optio with 8-hour samples ad with 15-miute samples. Am I permitted to use results of air samples collected at aother time or at a differet locatio from my iitial moitorig results? Yes, but the work coditios must have bee similar o the two dates, or at the two locatios. The criteria listed above for usig results from similar work coditios also applies i this situatio. Agai, if the aswer is o to oe or more of these questios, it is likely that you must coduct iitial moitorig. If the aswer to all of these questios is yes, the OSHA allows you to meet the iitial moitorig requiremets by usig persoal moitorig results collected for other employees at a earlier date or differet locatio i the workplace. Be sure to keep a documet explaiig why it was appropriate to use those results to meet your iitial moitorig requiremets. Which 15-miute period should I moitor? You must collect a 15-miute air sample durig the portio of the work shift whe you have reaso to believe that the employee s EtO exposure will be the highest. You may eed to collect several 15-miute samples durig the same shift (see text box Why Is It So Importat to Collect 15-Miute Samples? o the ext page). 11 Sectio 2

Why Is It So Importat to Collect 15-Miute Samples? Research suggests that EtO exposures above the 15-miute OSHA PEL cotiue to occur i workplaces that are ivolved i processig, usig, or hadlig products cotaiig EtO. Recet studies have also show that persoal moitorig activities ofte fail to detect accidetal exposures durig EtO leaks ad spills (LaMotage et al., 2004; LaMotage ad Kelsey 1998). Therefore, it is importat to carefully cosider the types of activities for which 15-miute moitorig is most useful. The followig examples should help provide some guidace: A commo situatio i which accidetal exposures to EtO may occur ivolves chagig EtO supply cyliders. Cosider collectig 15-miute persoal samples while the employees beig sampled are replacig EtO cyliders. Employees who work directly with, or i close proximity to, EtO sterilizers or similar equipmet should be moitored frequetly for shortterm (i.e., 15-miute) exposures to EtO at the times whe they are most likely to experiece exposure (such as whe the employee opes the door at the ed of the cycle, or while EtO is beig pumped i or out of the equipmet). ii. Periodic Moitorig Do I eed to repeat the EtO persoal moitorig ad, if so, what is the moitorig schedule? Whether you eed to repeat EtO persoal moitorig depeds o the results of your iitial persoal moitorig. Uder certai situatios, a log-term schedule for persoal moitorig for EtO must be established. Tables 1 ad 2 provide the periodic moitorig schedule required by the EtO stadard. The persoal moitorig results may also trigger other requiremets, which are listed i Tables 3 ad 4 later i this guidace documet. Table 1 Schedule for OSHA Exposure Moitorig If your iitial employee moitorig results show that employee exposure is below the 8-hour actio level are betwee the 8-hour actio level (0.5 ppm) ad the 8-hour permissible exposure limit (PEL) of 1 ppm (icludig the value 0.5 ppm) are above the 8-hour PEL of 1 ppm or above the 15-miute PEL of 5 ppm The... discotiue moitorig for oly those employees whose exposures are represeted by the iitial moitorig. coduct additioal 8-hour persoal exposure moitorig at least every 6 moths. coduct additioal persoal exposure moitorig (either 8-hour or 15-miute, depedig o the sample type that iitially exceeded the limit) at least every 3 moths. Where the 15 miute PEL is exceeded, frequet moitorig may be eeded to evaluate the employee s short-term exposures. See Table 3 - Actios Triggered by Air Sample Results. Sectio 2 12

Whe would I be allowed to reduce the frequecy of air moitorig? Test Date Example of 15-miute Air Moitorig Results for Employees Emptyig Sterilizer #3 Exposure Level Actio to Take Feb. 6 7.53 ppm Use PPE to protect employees. Repair vetilatio system power switch. Moitor 15-miute exposure level every 3 moths (ext test due by May 6). May 2 8.79 ppm Fix exhaust vetilatio fa (by May 4). May 6 5.22 ppm Adjust vetilatio suctio agle at machie door (by May 6 eveig). May 10 2.18 ppm Retest air wait at least 7 days (but ot more tha 3 moths) to do test. May 25 2.01 ppm Two test results are less tha the 15- miute PEL of 5 ppm ad the tests are more tha 7 days apart. We may discotiue moitorig! You may reduce the frequecy of periodic air moitorig for a employee or group of employees oly if two cosecutive air test results for that employee (or group) meet the criteria listed i Table 2. To qualify as cosecutive tests, the tests must be coducted oe after the other, at least a week apart, but ot more tha 3 moths apart. The results for the tests must both be below the 8-hour actio level or they must both be below the 15-miute PEL. Table 2 also lists the requiremets for discotiuig periodic tests. Table 2 Requiremets for Reducig or Discotiuig Moitorig If your periodic employee moitorig results had bee above the PEL (either the 8-hour TWA or the 15-miute excursio limit)* ad are curretly betwee the 8-hour actio level (0.5 ppm) ad the 8-hour PEL of 1 ppm (icludig the value 0.5 ppm) for two cosecutive tests (these samples must be collected at least 7 days apart, but o more tha 3 moths apart) are curretly less tha the 8-hour actio level (0.5 ppm) for two cosecutive tests (the samples must be collected at least 7 days apart, but o more tha 3 moths apart) curretly idicate that employee exposures are at or below the 15-miute PEL of 5 ppm (the excursio limit) for two cosecutive tests (the samples must be collected at least 7 days apart, but o more tha 3 moths apart) * See Sectio 2.A.iii for defiitios of OSHA Exposure Levels. The you ca decrease the 8-hour persoal moitorig frequecy from every 3 moths to every 6 moths. Note: If 15-miute exposures exceed the excursio limit of 5 ppm, you will still eed to coduct the 15-miute (excursio limit) moitorig at least every 3 moths, or more ofte as ecessary to evaluate short-term exposure. you are o loger required to coduct periodic persoal moitorig uless a chage i the workplace makes additioal moitorig ecessary. you may discotiue 15-miute (excursio limit) moitorig for those employees whose exposures are represeted by the moitorig. 13 Sectio 2

Whe must I resume air moitorig? You must start moitorig agai wheever there is a chage that could result i ew or additioal exposures to EtO. Examples of chages that would trigger EtO samplig iclude: Chagig EtO process equipmet or icreasig the volume of EtO used. Modifyig the exhaust vetilatio system. Hirig ew or iexperieced employees. Chagig work practices. You also must resume samplig ay time that you have a reaso to suspect that a chage could result i ew or additioal exposures. C. Actios Triggered by Air Sample Results Tables 3 ad 4 provide the lists of actios you eed to take if your EtO moitorig results exceed specific levels. Your eed to take these actios is based o how your results compare to the OSHA actio level ad/or PELs (8-hour ad/or 15-miute samples). Sectio 2 14

Table 3 Actios Triggered by Air Sample Results Result Iterpretatio: 8-Hour Sample Is equal to or above Actio Level but equal to or below PEL 8-Hour Sample Is above Permissible Exposure Limit 15-Miute Sample Is above Excursio Limit Other OSHA Stadards That Apply For More Iformatio, See Sectio: Actio Triggered by Moitorig Results: Develop ad put ito actio a writte compliace program for reducig exposure ad establishig a schedule for periodic leak detectio Take steps to reduce exposure levels with egieerig cotrols or other methods Not required Yes Yes 3.A ad.b Not required Yes Yes 3.C Provide respirators* Not required Yes Yes 1910.134 3.D Provide iformatio ad traiig Yes Yes Yes 1910.1200 4.A.i Establish a regulated area Not required Yes Yes, also if expected to exceed this level 4.A.ii Esure that cautio labels are fixed to cotaiers (also whe cotaier cotets are capable of causig or ca be reasoably expected to cause these exposure levels) Provide medical surveillace (if employee s exposure is more tha 30 days per year)** Yes Yes Yes 1910.1200 4.A.iii Yes Yes Not required 1910.1020 4.B Establish periodic air moitorig programs Yes, at least every 6 moths Yes, at least every 3 moths Yes, at least every 3 moths Table 1 * Respirators are required for those correctig a emergecy coditio, regardless of air cocetratios durig ormal operatios. ** Medical examiatios are also required if there is a exposure related to a emergecy situatio. View the provided stadard umber to see other OSHA stadards that apply. Review sectio umbers i this documet to see a summary of the additioal actio(s) required whe exposure levels are elevated. These sectios are ot iteded to be all-ecompassig istructios for compliace; istead, they expad o the limited iformatio i Table 3 by offerig you a overview of the geeral requiremets triggered by air samplig results. Retur to Sectio 2.A.iii.a - Permissible Exposure Limits. 15 Sectio 2

You must keep records of ay air moitorig that you perform. For more details o which records must be kept (ad for how log), see Sectio 5.A Retai the Required Exposure Moitorig Records. Table 4 Actios Triggered by the Air Samplig Process Other Actios Triggered by Air Moitorig Whe to Take Actio Other OSHA Stadards That Apply Post moitorig results withi 15 days of receivig them, or give employees the writte results idividually withi 15 days. Metio steps beig take to reduce exposures. Maitai records of moitorig for 30 years. Allow employees or their represetatives to observe air moitorig. The observer must wear PPE ad follow safety procedures provided by the employer. Ay time that samples are collected regardless of the results Ay time that samples are collected regardless of the results Ay time that samples are collected View the provided stadard umber to see other OSHA stadards that apply. 1910.1020 Sectio 2 16

D. How to Get Help with Air Moitorig If you eed help with air moitorig, cotact the OSHA O-Site Cosultatio Service office for your area. This service is free of charge to employers. Alteratively, you ca hire a idustrial hygiee cosultat who specializes i workplace air moitorig. For more iformatio o how to locate these services i your area, See Sectio 5.E - How to Obtai Further Assistace. Laboratories provide aalytical services ad sometimes advise employers o selectig air samplig equipmet ad test media. Some laboratories provide the media or loa the equipmet as part of the aalysis package. Laboratories that aalyze workplace air samples are typically listed i the Yellow Pages (uder evirometal aalysis) ad also o the America Idustrial Hygiee Associatio (AIHA) website. Whe selectig a laboratory, oe importat questio to ask is Does your laboratory meet the accuracy requiremets of OSHA s EtO stadard? See Sectio 5.B - Accuracy of Samplig ad Aalytical Methods. 17 Sectio 2

3. Exposure Reductio/Prevetio A. Methods of Detectig Emergecy EtO Releases There are a umber of optios available to moitor ad test for emergecy leaks of EtO. These methods may be appropriate i additio to, but ot istead of, persoal air moitorig. They caot be used as a substitute for persoal moitorig to satisfy OSHA persoal air moitorig requiremets. i. Emergecy Situatios The OSHA EtO stadard requires that each workplace have a writte pla for emergecy situatios. ii. Emergecy Pla for EtO The followig are some simple steps to esure that your workplace meets the emergecy pla requiremets i OSHA s EtO stadard: For employers with more tha 10 employees, the emergecy pla must be i writig ad available to employees. If you have 10 or fewer employees, the pla may be commuicated verbally to employees. The pla must cotai procedures for emergecy evacuatio, icludig the type of evacuatio ad exit route assigmets (refer to OSHA s stadard for Emergecy Actio Plas 29 CFR 1910.38). Although ot specifically required, you ca be proactive i emergecy plaig preparatios by coductig employee evacuatio drills for potetial EtO emergecies. You must have a system for alertig employees to emergecy EtO exposures. You do have the flexibility to choose ay effective method of alertig employees to potetial EtO releases that could result i harmful exposures. The pla must specifically provide that employees egaged i correctig emer- Sectio 3 18

Moitorig Systems Alarm systems basically fuctio as a moitor to test the surroudig air for EtO levels. To moitor EtO levels ear sterilizers, some employers fid it coveiet to istall a wallmouted or equipmet-mouted system. gecy coditios be equipped with respiratory protectio as required by 29 CFR 1910.1047(g) util the emergecy is abated ad must be implemeted i accordace with 29 CFR 1910.134, Respiratory Protectio. The pla must iclude the elemets cotaied i 29 CFR 1910.38 ad 29 CFR 1910.39, OSHA s stadards o Emergecy Actio Plas ad Fire Prevetio Plas. Commercially available alarms that moitor EtO levels ad use both visual ad soud alarms ca alert employees i oisy or crowded areas whe the level of EtO is higher tha it should be. Persoal alarm systems, wor by a employee, are useful whe employees hadle portable compoets of EtO sterilizatio equipmet. The EtO sesors used i persoal alarm systems ca detect emergecy release levels of EtO ad soud a alarm. Whe they iclude data-recordig ( loggig ) ability, the istrumets ca calculate a average exposure level that may be read directly from the istrumet scree. These istrumets, however, typically do ot provide accurate results at cocetratios at the PEL or lower ad, thus, are ot the best choice for measurig 8-hour TWA employee exposures. iii. Emergecy Alert Provisio The emergecy alert provisio of OSHA s EtO stadard allows employers to choose the most effective method of alertig employees. As part of the emergecy pla, you must develop a system for alertig your employees. The precise type of alert system is ot specified i the OSHA EtO stadard. OSHA cosiders the followig alert methods acceptable for a EtO moitorig system: A bell or other alarm system: A bell or alarm system must have a distictive sigal to alert employees to a EtO leak (refer to 29 CFR 1910.165 Employee Alarm Systems). A voice-activated system: Like other alarm types, this system must have a distictive sigal to alert employees to a EtO leak. Voice commuicatios: For those employers with 10 or fewer employees i a particular workplace, the requiremets uder OSHA s Employee Alarm Systems stadard state that direct voice commuicatio is a acceptable method of alertig employees, providig that all employees at their respective workstatios ca hear the alarm give i this maer. For workplaces with more tha 10 employees, simple voice commuicatio is ot acceptable. 19 Sectio 3

Is there a specific EtO level that I should use to trigger a alert? OSHA has ot established a alert level; you should choose a alert trigger level that is appropriate for your workplace. Whe evaluatig alarms, it is importat to remember that the alarm s purpose is to alert employees to uiteded ad hazardous EtO releases, rather tha to average EtO cocetratios measured over a 8-hour work shift. It is ot ecessary to base the EtO alarm trigger specifically o the OSHA actio level (0.5 ppm) or permissible exposure limits for 8 hours (1 ppm) or 15 miutes (5 ppm). You should also be aware that there is a wide rage i the cost ad sesitivity of commercially available moitors. Some systems alert employees to EtO levels greater tha 20 ppm, while other highly sesitive moitorig devices ca trigger a alarm at much lower levels, such as 1 ppm or eve lower (NIOSH, 1989). See Sectio 6.H - Emergecy Plaig ad Alert Systems. Retur to Sectio 2.A.ii.C - Leak Detectio. Sectio 3 20

Persoal Protective Equipmet OSHA s geeral PPE requiremets (29 CFR 1910.132, Persoal Protective Equipmet) madate that employers coduct a hazard assessmet of their workplaces to determie what hazards are preset that requie the use of PPE, provide employees with appropriate PPE, ad require them to use it. Employers must also maitai the PPE i a saitary ad reliable coditio. Uder OSHA s EtO stadard, employees who could have eye or ski cotact with EtO or EtO solutios must be provided appropriate protective clothig ad equipmet, at o cost to the employee, ad the employer must esure that the employees use it. Besides spectacles ad goggles, PPE such as special shields, spectacles with side shields, ad face shields ca protect employees from the hazards of splashes or mists. Employees exposed to EtO through ski absorptio ca be protected by had protectio, i appropriate cases. I some cases, employees must shield most or all of their bodies agaist EtO exposure i the workplace. You ca fid more iformatio about PPE, icludig the full text of OSHA s stadards, o OSHA s website at www.osha.gov. I additio, publicatios explaiig the subject of PPE i greater detail are available from OSHA. Persoal Protective Equipmet (OSHA 3151) ad Assessig the Need for Persoal Protective Equipmet: A Guide for Small Busiess Employers (OSHA 3151) are available o OSHA s website. B. Develop a Compliace Program If your exposure moitorig results are at a level that requires you to develop ad put ito actio a writte compliace program, write a memoradum or summary report that outlies the steps you eed to take at your facility to comply with the EtO stadard. This documet will serve as your writte compliace program. Iclude some backgroud iformatio, such as which employees or job categories may be exposed to EtO ad the kow or suspected sources of exposure. The describe what methods are beig or will be take to cotrol exposures ad iclude a schedule of leak-detectio surveys, a list of persoal protective equipmet (PPE) employees will wear to protect their eyes ad ski from possible cotact with EtO or EtO solutios (usig PPE selected by methods required i 29 CFR 1910.132, OSHA s Persoal Protective Equipmet stadard), ad a writte emergecy pla. Outlie how you will implemet the required actios triggered by the air samplig results obtaied i your facility. You may wish to iclude a actio pla worksheet, such as the oe available as Appedix A i OSHA s Small Busiess Hadbook. Be sure to follow this pla ad take the ecessary steps that will put the pla ito actio. You are required by the EtO stadard to review the pla at least every 12 moths. If your plaed actios chage, be sure to update the writte compliace program to match your pla. Remember that rotatig employees betwee differet workstatios does NOT costitute a acceptable compliace program. Retur to Table 3 - Actios Triggered by Air Sample Results. 21 Sectio 3

C. Reduce Exposures with Egieerig Cotrols or Other Methods If your exposure moitorig results are at a level that requires you to take steps to reduce exposures with egieerig cotrols or other methods, ivestigate optios for modifyig or eclosig your EtO equipmet. Also cosider optios for improvig vetilatio to capture ad remove EtO before employees are exposed. Trai employees to use work practices that will help lower exposure levels. Oe example of such a practice is waitig a pre-determied time before opeig the sterilizer door whe the equipmet fiishes its cycle. Also, employers may wish to upgrade their equipmet with improved sterilizers that have built-i exposure cotrol features (e.g., built-i aerators). Employers ca ofte obtai helpful iformatio o exposure reductio methods from the sterilizatio equipmet maufacturer, trade associatios, OSHA Cosultatio Program offices, ad private cosultats that specialize i idustrial vetilatio or idustrial hygiee (see Sectio 5.E - How to Obtai Further Assistace). Retur to Table 3 - Actios Triggered by Air Sample Results. Sectio 3 22

Photos courtesy of NIOSH D. Provide Respiratory Protectio If your exposure moitorig results are at a level that requires you to provide respirators, a writte respiratory protectio program must describe how the respirators are selected, stored, cleaed, ad maitaied at your facility. A writte program is also ecessary whe employees use respirators for certai tasks, as required by the EtO stadard (e.g., maiteace ad vessel cleaig activities for which cotrols are ot feasible, operatios for which cotrols are ot yet sufficiet to reduce exposures, ad for cotrollig emergecy releases of EtO). A positive-pressure supplied-air respirator might be required. To protect the eyes, use a respirator with a full-facepiece (above) or hood. The writte respiratory protectio program must state how employees are traied, medically qualified, ad fit tested for respirator use. As part of your program, you must try to reduce employee exposures by istallig egieerig cotrols ad modifyig work practices so that respirators will ot be ecessary. For more iformatio, icludig iformatio o selectig respirators, review the respiratory protectio requiremets of OSHA s EtO stadard i sectio 29 CFR 1910.1047(g). For assistace with respiratory protectio program requiremets, review OSHA s Respiratory Protectio stadard (29 CFR 1910.134) ad the documets listed i Sectio 6.C Respiratory Protectio ad Persoal Protective Equipmet. Retur to Table 3 - Actios Triggered by Air Sample Results. 23 Sectio 3

4. Other Requiremets A. Employee Iformatio ad Traiig i. Hazard Commuicatio If your exposure moitorig results are at a level that requires you to provide iformatio ad traiig, you must arrage a traiig class for all employees who are potetially exposed to EtO at or above the actio level or the 15-miute excursio limit. New employees must be traied before they are assiged to a area where exposure might occur. You must also provide aual (repeated every year) traiig to all potetially exposed employees. See Sectio 5.E - How to Obtai Further Assistace for iformatio o locatig sources of help with employee traiig. The traiig must cover the followig topics: The OSHA EtO stadard, icludig a explaatio of the requiremets of the stadard ad its Appedices A ad B. Employees must also be iformed (1) that a copy of the stadard is available to them ad (2) where they ca fid a copy. The copy of the stadard may be a paper copy stored i a area ope to employees. Alteratively, the copy may be i a electroic format (accessible from a computer), but oly if every potetially exposed employee ca access a workplace computer ad kows how to locate the electroic copy. Ay operatios i the employees work area where EtO is preset or may be used. The medical surveillace program for employees exposed to EtO ad a explaatio of the iformatio cotaied i Appedix C of the OSHA EtO stadard. The ways EtO is detected ad moitored at your facility (for example, by persoal exposure moitorig, cotiuous air moitorig devices, or other methods). The physical ad health hazards associated with EtO use ad potetial exposures. Sectio 4 24

The steps employees ca take to protect themselves from the hazards of EtO, icludig the procedures used i your workplace to protect employees (e.g., work practices, emergecy procedures, ad persoal protective equipmet). Details of the workplace hazard commuicatio program, the correspodig labelig system, ad how employees ca fid ad use hazard iformatio. Havig access to ad beig familiar with the material safety data sheet (MSDS). Madatory Sig for Regulated Area DANGER ETHYLENE OXIDE CANCER AND REPRODUCTIVE HAZARD AUTHORIZED PERSONNEL ONLY RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN THIS AREA For additioal iformatio o employee hazard commuicatio ad traiig see Sectio 6.E - Hazard Commuicatio. Retur to Table 3 - Actios Triggered by Air Sample Results ii. Establish Regulated Areas If your exposure moitorig results are at a level that requires you to establish regulated areas i your facility, you must idetify, mark, ad make employees aware of the regulated areas i their workplaces. Idetify regulated areas by determiig where EtO levels may exceed the permissible exposure levels (PELs) i your facility. Also iclude areas where the EtO levels ca reasoably be expected to exceed the excursio limit. These two types of areas will be your regulated areas. You must oly allow authorized persos to eter regulated areas. Mark the boudary of these regulated areas by postig required sigs ad usig ay other methods you decide are eeded to prevet uauthorized people from eterig the areas. The goal is to limit the umber of people i regulated areas to the miimum umber eeded to do the work. If the regulated area is a portio of a larger space, you must use sigs to mark each poit where a employee might eter the regulated area. See box at left for what the sigs must state. 25 Sectio 4

Cosider usig a combiatio of methods to mark the area ad restrict etry. I additio to postig sigs, you might also lock the doors to keep uauthorized employees from eterig a room that is a regulated area. Other methods of alertig people to the potetial hazard iclude chagig the floor color, addig physical barriers such as gates, feces, or partitios, or takig other steps to mark the boarder of the regulated area. Regardless of the methods used, it is importat that you make sure that uauthorized employees are able to recogize the regulated areas ad kow to stay out. For example, if you use special floor markigs to idicate the regulated area, you must also trai employees so that they kow what that floor markig meas. Retur to Table 3 - Actios Triggered by Air Sample Results. A Cotaier Label Statemet Warig Agaist Breathig Cotamiated Air is Madatory Sectio 4 USE ONLY WITH ADEQUATE VENTILATION OR RESPIRATORY PROTECTION 1 1 This is the statemet suggested by the Califoria Code of Regulatios, Title 8, Subchapter 7 - Geeral Idustry Safety Orders, Sectio 5520 - Ethylee Oxide < http://www.dir.ca.gov/title8/5220.html> iii. Esure that Cautioary Labels are Fixed to Cotaiers All cotaiers of EtO, the cotets of which are capable of causig employee exposure at or above the actio level or may reasoably be foresee to cause exposure above the 15-miute excursio limit, must be properly labeled. Be sure that employees uderstad that the labels o cotaiers must ot be removed or covered. Check icomig chemical ad gas cotaiers to be sure that the labels are readable ad firmly attached whe they are delivered to your facility. EPA regulates EtO as a pesticide uder the Federal Isecticide, Fugicide ad Rodeticide Act (FIFRA) whe it is used as a fumigat or sterilat for medical items. As a part of this regulatio, EPA has specific requiremets for labels for EtO cotaiers. I 1996, EPA modified its FIFRA labels to iclude statemets madatig that all users of EtO-cotaiig sterilats ad fumigats observe the requiremets of 29 CFR 1910.1047. The label must also iclude a warig agaist breathig air cotamiated with EtO. Oe example of a suitable label at bottom left. 26

If the label o a cotaier i your facility is damaged, you may copy the iformatio to a ew label ad attach it to the cotaier, or you may cotact the product maufacturer to see if you ca obtai a replacemet label. iv. MSDS Hazard Commuicatio stadard requires that you maitai a MSDS, which the maufacturers or distributors are required to provide to you. It must be kept i a area that is accessible to employees exposed to EtO. Retur to Table 3 - Actios Triggered by Air Sample Results. B. Medical Surveillace If your exposure moitorig results are at a level that requires you to eroll employees i a medical surveillace program, you must develop a medical surveillace program that provides required medical exams for employees who meet certai criteria. Specifically, the OSHA EtO stadard requires medical exams for all employees who are exposed to EtO at or above the actio level (0.5 ppm) for at least 30 days per year or if ay employees are exposed to EtO durig a emergecy evet. Emergecy meas ay occurrece such as, but ot limited to, equipmet failure, rupture of cotaier, or failure of cotrol equipmet that is likely to or does result i a uexpected sigificat release of EtO. Importat poits to remember whe determiig whether a employee meets the criteria for the medical surveillace program: Recogize that the 30 days of exposure might be scattered throughout the year. Therefore, if the umber of days of exposure for oe employee adds up to a total of 30 or more days i oe year, that employee must be icluded i the medical surveillace program. Cout each day whe the employee has 8-hour EtO exposure at or above the actio level (0.5 ppm), eve if the employee is wearig a respirator. Iclude i the program ay ewly hired employee who is takig a job that ivolves this amout of exposure. 27 Sectio 4

If a employee wears a respirator, OSHA s Respiratory Protectio stadard, 29 CFR 1910.134, requires that the employee receive a medical evaluatio for respirator use, eve if the employee is ot icluded i the EtO Medical Surveillace Program. If you are certai that a employee will be exposed to the EtO actio level for less tha 30 days per year (for example: exposed oly oce per moth, or 12 times per year), the you do ot eed to iclude that employee i the medical surveillace program. Eroll a employee i the medical surveillace program as soo as you realize that he or she meets the program criteria. If workig coditios chage so that a employee who was ot icluded i the program will ow be exposed at or above the actio level for 30 or more days i the year, eter that employee i the program as soo as you kow of the chage. The OSHA EtO stadard requires that employers provide their employees who are i the medical surveillace program a opportuity to have medical exams at the employer s expese. This meas that the employer must pay for the exams. See Sectio 5.F - How to Fid a Healthcare Provider for Your Medical Surveillace Program. Each employee who is erolled i the medical surveillace program must be offered several differet types of exams: a iitial exam, a aual (repeat) exam each year, ad a fial exam. Additioal evaluatios might also be required uder certai circumstaces. Although OSHA s EtO stadard provides miimum requiremets, it is up to the healthcare provider to determie what specific medical tests to iclude i the exam. See Sectio 5.G - What a Medical Exam Must Iclude. 1. The iitial exam must be performed before the employee is assiged to work i a area where his or her exposure may be at or above the actio level for 30 or more days per year. 2. The employer must cotiue to offer a aual (repeat) medical exam each year as log as the employee is exposed to EtO above the actio level o at least 30 days per year. Sectio 4 28

3. The employee must also be offered a fial medical examiatio: Whe the employee leaves the place of employmet (i.e., retires, quits, or is fired from the job). Whe the employee trasfers to aother job with less EtO exposure (i.e., exposure below the criteria for the medical surveillace program). 4. Additioal medical evaluatios must be provided if: The employee develops symptoms of possible overexposure to EtO. The employee requests medical advice about whether their past or curret EtO exposure could affect his or her ability to have a healthy baby. The healthcare provider determies that more frequet exams are ecessary. The employee is exposed durig a emergecy. Ethylee oxide stadard The exams must be provided at o cost to the employee, without loss of pay, ad at a reasoable time ad place. This meas schedulig the exam durig workig hours ad allowig the employee to atted the exam o paid time or schedulig it at a reasoable time ad place outside workig hours ad payig the employee for the time ad travel expeses icurred i attedig the exam. The employer must provide the healthcare provider with certai iformatio, such as: A copy of OSHA s EtO stadard ad Appedices A, B, C ad D (at left). A descriptio of the employee s job duties associated with EtO. The employee s EtO exposure level (or aticipated exposure level). A descriptio of ay PPE ad/or respiratory equipmet used by the employee. Ay iformatio from previous medical examiatios ot otherwise available to the healthcare provider (e.g., if the previous exam was coducted by aother healthcare provider). 29 Sectio 4

Employee medical records. The medical record for each employee shall be preserved ad maitaied for at least the duratio of employmet plus thirty (30) years, Quote from OSHA s stadard o Access to Employee Exposure ad Medical Records, 29 CFR 1910.1020 Exams related to OSHA s EtO stadard may be combied with other exams that the employer might eed to provide for a employee. For example, if the employee will wear a respirator, ay medical exam that the healthcare provider determies is ecessary for respirator qualificatio may be performed durig the same visit as the EtO medical surveillace exam. After each medical exam, the healthcare provider will sed to the employer a physicia s writte opiio that idicates whether the healthcare provider foud ay coditio(s) that would place the employee at icreased risk if exposed to EtO. The writte opiio must also list ay limitatios o the employee s persoal protective equipmet use, ad a statemet that the physicia has iformed the employee of the results of the exam. To help keep medical iformatio private, the employer should istruct the healthcare provider ot to reveal i the writte opiio give to the employer ay specific fidigs or diagoses that are urelated to EtO exposure. The employer must provide the employee with a copy of the writte opiio withi 15 days of receivig it from the physicia. The employer must keep the writte opiio as log as the idividual is employed at that workplace ad for a additioal 30 years beyod the last date that the idividual is employed at the workplace. Alog with the writte opiio, the employer should keep ay other iformatio provided by the physicia uder OSHA s EtO stadard, the employee s ame ad social security umber, ad a record of ay EtO-related medical complaits made by the employee. Follow the requiremets for maitaiig these records ad allowig employees to access them established i 29 CFR 1910.1020, OSHA s stadard o Access to Employee Exposure ad Medical Records. For additioal resources, also see Sectio 6.G - Medical Moitorig. Retur to Table 3 - Actios Triggered by Air Sample Results. Sectio 4 30

5. Additioal Compliace Details ad Helpful Iformatio A. Retai the Required Exposure Moitorig Records You must maitai documetatio of your employees exposure moitorig. Employee moitorig documetatio must iclude the followig: The date of measuremet. The operatio ivolvig exposure to EtO that is beig moitored. Samplig ad aalytical methods used ad evidece of their accuracy (see Sectio 5.B - Accuracy of Samplig ad Aalytical Methods). Number, duratio, ad results of samples take. Type of protective devices wor, if ay. Name, social security umber, ad exposure levels of the employees whose exposures are represeted. The employer is required to maitai this record for at least 30 years beyod last date of employmet (followig the requiremets of 29 CFR 1910.1020). Employees must be iformed of their persoal moitorig results withi 15 workig days after the employer receives the results. If you use respresetative samplig, i.e., results from other employees (or other locatios or dates) i place of iitial moitorig results, you must documet your reasos for cosiderig the workig coditios ad exposure levels to be similar. Retur to Table 3 - Actios Triggered by Air Sample Results. 31 Sectio 5

Istrumet Maufacturer s Certificate of Calibratio For Ethylee Oxide Detectio Meter Maufacturer: Model: Serial #: Date of calibratio: Next calibratio due: Coditios of testig: Accuracy: Authorized sigature B. Accuracy of Samplig ad Aalytical Methods To record the samplig ad aalytical methods, documet the type of equipmet you used to obtai the samples (make, model) ad the samplig media o which you collected the samples (maufacturer, descriptio, part umber). Whe coductig samplig required by OSHA s EtO stadard, you may oly use samplig ad aalytical methods that meet miimum stadards of accuracy which appear i OSHA s EtO stadard 29 CFR 1910.1047(d)(6). If the EtO exposure level is at the PEL (1 ppm) you may oly use methods that provide a cofidece level of 95 percet ±25 percet. If the EtO level is at the actio level (0.5 ppm) your method must be able to achieve a cofidece level of 95 percet ±35 percet. Moitorig shall be accurate to a cofidece level of 95 percet ± 35 percet for the excursio limits. The laboratory that aalyzes your samples ca cofirm that the method will meet this level of accuracy. For your records, ask the laboratory to provide the ame of the aalytical method ad evidece that the aalysis meets OSHA s accuracy requiremets for EtO. If a direct-readig istrumet is used to obtai samples, keep a copy of the most recet calibratio documetatio ad of the istrumet maufacturer s specificatios for the accuracy of the istrumet. At this time, most direct-readig istrumets are iteded to alert the user to very high levels of EtO caused by a emergecy release. These istrumets typically do ot meet the accuracy requiremets for persoal moitorig at the level of the PEL or actio level. Retur to Sectio 2.D - How to Get Help with Air Moitorig. Sectio 5 32

C. Exemptios from Iitial Moitorig Iitial moitorig is ot always required. Employers are exempt from iitial moitorig for a specific job or task if objective data show that airbore releases associated with the processig, use, or hadlig of products cotaiig EtO are ot capable of resultig i cocetratios at or above the OSHA actio level (0.5 ppm). These objective data might iclude specific iformatio from chemical maufacturers, idustry studies, or trade associatios that documets why your facility s processig, use, or hadlig of EtO would ot result i workplace cocetratios exceedig the actio level. To show that a job or task is exempt, you will eed the followig supportig iformatio (see 29 CFR 1910-1047(k)(i)): The ame (make, model, or product ame) of the equipmet or product that qualifies for a exemptio (e.g., a maufacturer might have show that a specific type of sterilizer or a certai sterilat solutio qualifies for a exemptio as log as it is used as istructed by the maufacturer). The source of the objective data (where you obtaied the iformatio). The testig protocol, results, ad/or aalysis of data. The operatio (job or task) at your facility that is exempt ad a explaatio of why the operatio is exempt. Specifically describe how the objective data apply to your situatio ad how the data support your exemptio. Ay other data relevat to the operatios, materials, processes, or employee exposures covered by the exemptio. Ay other data relevat to the operatios, materials, processes, or employee exposures covered by the exemptio. Objective data records must be kept as log as the employer relies o the data to show that moitorig is ot required. Depedig o the type of jobs performed at the facility ad the objective data that are available, the data might show that all of the operatios i the facility are exempt. Alteratively, the data might show that oly oe job is exempt, while other jobs i the facility require iitial moitorig. Retur to Sectio 2.A.ii - OSHA Requiremet for Air Moitorig. Retur to Sectio 2.B.i - Iitial Moitorig. 33 Sectio 5

Try to sample the employee s etire 8-hour work shift. If the work shift is more tha 8 hours, cosult a idustrial hygieist for assistace with your air samplig pla (see the ext sectio o How to Obtai Further Assistace). D. Work Shifts of Other Tha 8 Hours Whe you collect a 8-hour sample, OSHA expects you to collect the sample for the legth of the whole work shift, o matter how log it is. The shift might be more or less tha 8 hours. Although ot every sample will have a duratio of exactly 8 hours, ay sample to determie exposure to the OSHA actio level or 8-hour permissible exposure limit must be compared to a 8-hour sample result. To avoid cofusio caused by samples collected for more or less time, OSHA allows you to use a simple equatio that coverts ay full-shift sample result to a 8-hour equivalet result (also called a 8-hour time-weighted average or a 8-hour TWA result). Equatio: C 8 = [ C A (T A ) ] / T 8 C 8 = The 8-hour equivalet result for your sample (i ppm) C A = The actual result (cocetratio) for your sample (i ppm) T A = The actual time durig which your sample was collected (i miutes) T 8 = 480 miutes (this is the umber of miutes i 8 hours) Fortuately, most aalytical laboratories will do the calculatio for you. Ask the laboratory to Report the full-shift results as 8-hour time weighted averages (or 8-hour TWAs). You do ot eed to make this arragemet for 15-miute samples, which should always be collected for exactly 15 miutes. Whe exposure levels are high, it may be ecessary to collect a series of mid-legth samples (e.g., 1 to 2 hours each) istead of a sigle 8-hour sample for a employee. I this case, ask the laboratory to combie all of the results from oe employee to create a sigle 8-hour TWA result. Retur to Sectio 2.A.iii.a - Permissible Exposure Limits. Sectio 5 34

E. How to Obtai Further Assistace i. Work with Idustry ad Supplier Represetatives Talk to the maufacturer of the sterilizatio equipmet used i your facility. The compay may have helpful recommedatios for adjustig your equipmet ad implemetig egieerig cotrols to miimize employee exposure. Cotact the maufacturer of the EtO product that you use (gas or solutio). As a beefit to customers, several maufacturers offer materials ad services that ca help you with traiig ad other OSHA compliace activities. Cosultatio Program Iquire about assistace offered through idustry trade associatios ad employees uio health ad safety programs. Check with your workers compesatio isurace carrier. Some isurace carriers will provide or recommed professioals who ca assist you. ii. Locate a Idustrial Hygiee Cosultat You ca obtai the services of a health ad safety professioal, called a idustrial hygieist, who has expertise i employee traiig, exposure moitorig, egieerig cotrols, respiratory protectio, compliace program developmet, ad other related areas. This type of professioal assistace is offered through several sources: OSHA offers free health ad safety cosultatio services through offices i each state. For more iformatio, visit www.osha.gov/dcsp/smallbusiess/cosult.html. Alteratively, you might wish to cotract with a private idustrial hygiee cosultat. To fid a private cosultat i your area, ask for recommedatios from other employers whose employees hadle chemicals. You ca also look i the Yellow Pages uder a headig such as Evirometal Services. 35 Sectio 5

Sources of Assistace Idustry ad supplier represetatives OSHA (or State-OSHA) Cosultatio Programs Idustrial hygiee cosultats Laboratories specializig i evirometal aalysis Aother way to locate a private cosultat is through the America Idustrial Hygiee Associatio (AIHA) Cosultats Listig o the Iteret. To use the AIHA cosultats listig, go to the AIHA website (www.aiha.org) ad click o Cosultats Listig, the choose Cosumer. You ca eter your city/state ad choose a cosultat specialty for your search. Depedig o the type of assistace eeded, may employers cocered about EtO might be most iterested i a cosultat with a specialty i oe or more of the followig categories: Vetilatio/egieerig Exposure assessmet Respiratory protectio/ppe Commuicatio/traiig iii. Fid a Aalytical Laboratory You ca locate a idustrial hygiee laboratory that will aalyze EtO exposure moitorig samples by usig the same sources listed above for locatig a idustrial hygieist. If you obtai the services of a idustrial hygiee cosultat, that idividual will also be able to coordiate laboratory services, if ecessary. Retur to Sectio 2.D - How to Get Help with Air Moitorig. Retur to Sectio 3.C - Reduce Exposures with Egieerig Cotrols or Other Methods. Retur to Sectio 3.D - Provide Respiratory Protectio. Retur to Sectio 4.A.i - Hazard Commuicatio. Sectio 5 36

F. How to Fid a Healthcare Provider for Your Medical Surveillace Program Medical exams must be performed by, or uder the supervisio of, a licesed physicia. May employers locate a healthcare provider who performs occupatioal medical surveillace services (also called medical moitorig ) by askig other local employers for recommedatios. Some hospitals ad cliics offer medical surveillace services or ca recommed a medical office that does. The followig questios might help you determie whether a healthcare provider is kowledgeable about geeral OSHA requiremets: Are you familiar with OSHA s recordkeepig requiremets? Do you provide medical evaluatios of employees required to wear respirators? Do you have a process for maitaiig employee medical records accordig to 29 CFR 1910.1020? A healthcare provider who regularly coducts occupatioal medical evaluatios, is likely to aswer yes to each of these questios. The provider should also be able to offer a reasoable descriptio of how these processes are accomplished at the medical office. You must provide the healthcare provider with a copy of the EtO stadard, or metio that he or she must get the stadard at OSHA s web site. I 29 CFR 1910.1047(i), the stadard provides iformatio o the patiet medical history ad tests that the healthcare provider must iclude i the medical exam for EtO. Appedix C of the stadard offers additioal details for healthcare providers ad idividuals who are iterested i more iformatio. Retur to Sectio 4.B - Medical Surveillace. 37 Sectio 5

G. What a Medical Exam Must Iclude The healthcare provider must iclude the followig elemets i the routie medical exam: Medical ad work histories with special emphasis directed to symptoms related to the pulmoary, hematological, eurological, ad reproductive systems ad to the eyes ad ski. Physical examiatio with particular emphasis give to the pulmoary, hematological, eurological, ad reproductive systems ad to the eyes ad ski. Complete blood cout to iclude at a miimum a white cell cout (icludig differetial cell cout), red cell cout, hematocrit, ad hemoglobi. Ay laboratory or other test that the examiig physicia deems ecessary based o soud medical practice. OSHA s EtO stadard allows the healthcare provider to decide whether other tests are ecessary. If requested by the employee, the medical examiatios shall also iclude pregacy testig or a laboratory evaluatio of fertility if cosidered appropriate by the physicia. Retur to Sectio 4.B - Medical Surveillace. Sectio 5 38

H. Accessig OSHA Stadards o the Iteret OSHA s website cotais a complete listig of all OSHA stadards. To see the complete text of ay stadard listed i this documet, you may go to www.osha.gov. Oce at OSHA s website, select the Regulatios tab at the top. The click the tab for Geeral Idustry. You ca also access stadards by selectig Laws & Regulatios at OSHA s website. All geeral idustry stadards start with 1910., followed by aother umber (for example, the Ethylee Oxide stadard is umber 1910.1047). Scroll dow the list of stadards to the umber of the stadard that you wat to view. www.osha.gov 39 Sectio 5

No matter what it is called, if a substace is ethylee oxide the CAS umber listed o the material safety data sheet (MSDS) for the substace will be CAS Number 75-21-8. I. Other Names for Ethylee Oxide The term ethylee oxide is ofte shorteed to: EtO EO E.O. The Natioal Istitute for Occupatioal Safety ad Health (NIOSH) also lists the followig other terms (syoyms) that are sometimes used for ethylee oxide (NIOSH 2006): 1,2 - Epoxy ethae 1,2 - Epoxyethae Amprolee Aprolee Aprolie CAS #: 75-21-8 Dihydrooxiree Dimethylee oxide ENT - 26263 Epoxyethae Ethee oxide Ethox FEMA No. 2433 Merpol NCI - C50088 Oxacyclopropae Oxae Oxidoethae Oxira Oxirae Oxiree, dihydro - Oxyfume Oxyfume 12 RCRA waste umber U115 Sterilizig gas ethylee oxide 100% T - Gas alpha,beta - Oxidoethae Retur to Sectio 1 - Overview. Sectio 5 40

J. Breathig Zoe Retur to Sectio 2.A.ii.a - Persoal Moitorig. Persoal air samples should represet the air the employee breathes. Positio the sample media (air itake poit) i the breathig zoe, the hemisphere forward of the shoulders with a radius of approximately six to ie iches ad cetered o the employee s ose. 6-9 6-9 6-9 6-9 6-9 6-9 41 Sectio 5

K. Passive Diffusio Dosimeter (or Moitor) Before usig a passive dosimeter Passive dosimeter Whe plaig air moitorig, first decide which jobs ad which employees will be moitored. The determie whether passive dosimeters are the right moitorig method for the expected situatios (i.e., does the moitorig sessio ivolve a routie 8-hour period with exposure levels similar to the PEL or lower, or a 15-miute period with exposure i the rage of the excursio level?). If the work shift will be shorter or loger tha 8 hours, discuss this possibility with the laboratory or a idustrial hygieist before you start the test. Some passive dosimeters become less accurate if used for too short or too log a period of time. If your work shifts vary greatly, you might eed to use a differet samplig method. The same is true if you thik that your EtO levels are likely to exceed OSHA s PEL, which might overload the dosimeter. Aother possible problem is iterferece from other chemical substaces i the air. If other chemicals will also be used, you will eed to determie whether they could affect the results. Frot Back You may eed professioal advice to make these decisios. I such cases, cosult the laboratory, a idustrial hygieist, or your Cosultatio Service to get help plaig a samplig procedure that will work well i your workplace. Professioal advice may save you time ad effort. It ca also icrease your cofidece that the resources you exped o samplig ad aalysis will provide you with valid results ad are ot wasted o iappropriate moitorig methods. See Sectio 5.E - How to Obtai Further Assistace. Sectio 5 42

If you decide to use a passive dosimeter Tell your laboratory or dosimeter supplier what type of samplig you are plaig. This iformatio will help esure that you order the correct type ad umber of dosimeters. Be sure to iquire about the eed for blak samples used for quality assurace purposes. Whe you call the laboratory, you should be able to aswer the followig questios: Package of samplig supplies. What air cotamiat will you be moitorig (e.g., ethylee oxide)? What will be the sample duratios (i.e., 15-miute or 8-hour/full-shift)? How may samples of each type do you pla to collect? (This will also affect how may blak quality assurace samples you will eed to submit to the lab.) Whe do you pla to moitor employee exposure? How soo do you eed your results? (rush aalysis is typically available, but at a premium cost). Each passive dosimeter will arrive from the supplier or laboratory i a airtight package (a caister or pouch). The dosimeter typically comes with istructios. Before you begi samplig, carefully read the istructios ad be sure that you uderstad them. If ecessary, cotact your dosimeter supplier for clarificatio. The samplig period begis whe you expose the passive dosimeter to air. Do ot ope the airtight cotaier util you are ready to begi moitorig! Do ot ope the sealed cotaier or pouch util it is time to begi collectig the sample. Before you begi samplig, talk to employees so that they uderstad the process. Provide adequate advace otice to afford employees (icludig those who work i the area but will ot be moitored) or their represetatives a opportuity to observe the moitorig if they wish. 43 Sectio 5

Ope the cotaier, remove the dosimeter, ad label it. Begiig a samplig period Start 8-hour, full-shift samples at the begiig of the work shift so that you ca moitor the whole shift. Start 15-miute samples so that the period of highest exposure is icluded i the 15 miutes. Oce you are ready to begi air moitorig, ope the cotaier or pouch, remove the dosimeter, ad label it with the date ad time the samplig period is started, the sample umber, ad the ame of the employee or area. Documet the sample. For each sample, record o a samplig form or i a log book the same iformatio that you wrote o the dosimeter label, plus ay additioal details that may be useful or relevat. Useful details iclude the temperature ad relative humidity i the work area, a descriptio of the employee s activities, the products ad equipmet used by the employee, the ame of the perso performig the samplig, the istrumets used to coduct the moitorig, ad iformatio about other chemicals also used i the work area durig the shift. For persoal moitorig, place the dosimeter o the employee s lapel (withi the breathig zoe, as described i the previous sectio). Persoal moitorig. Sectio 5 44

Area moitorig. For a geeral area sample, place the dosimeter i a ope space, away from walls ad closed spaces that might have poor air circulatio. Results could be iaccurate if air movemet across the face of the dosimeter is ot adequate. Clip the dosimeter to a clea object that will help keep the dosimeter suspeded well away from surfaces. Hadle blak samples (quality assurace samples) i the same way as your other samples, except do ot expose the dosimeter to air for the samplig period. Istead, ope the dosimeter ad the immediately seal it accordig to the istructios that came with the dosimeters. Issue the blak sample a umber as if it were a air sample; however, istead of otig the sample start ad stop time, write BLANK o the sample form. Edig the samplig period Sap-o cap. At the ed of the samplig period, eter o the samplig form or log book the time that the samplig period eded, the remove the passive dosimeter from the employee or work area. Immediately seal the dosimeter usig the same process that you used for the blak sample (followig the istructios that came with the dosimeter). The model of dosimeter show here icluded a plastic cover that saps i place to seal the dosimeter. Small holes i the cover, to be used by the laboratory durig aalysis, must be covered with the attached caps. This dosimeter ca ow be packaged ad shipped to the laboratory alog with a copy of the samplig form. Sedig samples to the laboratory for aalysis Complete the label. The procedure for sealig ad shippig will be differet for each model of passive dosimeter. Cosult the istructios that come with your dosimeter. Sectio 6.B - Coductig Persoal Moitorig cotais liks to Web-based istructios for several models ad brads of dosimeters. 45 Sectio 5

May samples, icludig most ethylee oxide samples, ca be wrapped i paddig ad shipped to the laboratory i a rigid (crushproof) box. Some types of samples, however, require refrigeratio or require you to avoid some packagig materials that might cotamiate the sample. To be certai, ask the aalytical laboratory whether your sample eeds ay special hadlig. Follow the laboratory s shippig istructios. If the laboratory directs you to ship a sample o ice or uder refrigeratio, you ca put the sample i a rigid, compact ice chest ad add a freezer pack to ship the sample usig a overight express service. Use care i packig the sample to prevet it from beig battered by the freezer pack if the ice chest receives rough hadlig i trasit. For more iformatio o exposure moitorig for employees, see Sectio 6.B - Coductig Persoal Moitorig. Retur to Sectio 2.A.ii.a - Persoal Moitorig. Sectio 5 46

Plastic tube from pump o hip. L. Air Samplig Pump ad Sorbet Tube Before usig a air samplig pump ad sorbet tube Several importat factors must be cosidered before you use a pump ad sorbet tube. First, do you have the expertise ad equipmet eeded to perform the task? If you have access to appropriate equipmet, do you also have the kowledge to determie a appropriate samplig procedure that will provide useful (ad valid) results? Sorbet tube If you are ot sure, you should cosider obtaiig professioal assistace from a idustrial hygieist or your o-site Cosultatio Service. The followig iformatio will help you uderstad what is ivolved i the samplig process. Overview To coduct this type of moitorig, you will eed to: Pump Obtai sample media (sorbet tubes of a appropriate type), a persoal air samplig pump that provides a suitable air flow rate, ad a air flow meter to calibrate the pump. Esure that the pump battery is adequately charged. Calibrate the pump before ad after the samplig period. Correctly place the pump ad sorbet tube o the employee (see iformatio i the subsectio o preparig the equipmet ad collectig samples preseted later i this sectio). Moitor the pump performace durig the air samplig period. Chage the media (sorbet tube) at appropriate itervals. Maitai accurate records for use by you ad the aalytical laboratory. 47 Sectio 5

About sorbet tubes A sorbet tube cosists of a slim glass tube cotaiig a material (sorbet) that traps certai air cotamiats. Oe example of a sorbet material is specially treated charcoal, to which may air cotamiats adhere. Differet air cotamiats require differet types of sorbet tubes ad samplig procedures. The sorbet tube supplier will help esure that you obtai the correct tube for your iteded purpose. A typical sorbet tube. These tubes are easily overloaded with air cotamiat if the samplig period is log or if the cocetratio of air cotamiat is high. Results from a overloaded tube may be ivalid. To avoid this problem, it may be ecessary to use several sorbet tubes, oe after the other, to sample a etire shift. Sectio 5 48 It is also importat to sample a large eough volume of air o each sorbet tube, so that the cotamiat ca be detected at the cocetratio of iterest (for EtO, this level is usually the OSHA 15-miute PEL or the 8-hour actio level). This meas that i order to obtai a valid result, each tube must be attached to the pump for o less tha a miimum amout of time, but o more tha a maximum time. Ufortuately, the miimum ad maximum times vary depedig o the model of tube used, the specific air cotamiat beig measured, the aticipated cocetratio of cotamiat i the air, the air flow rate through the pump, ad factors associated with the aalytical laboratory methods. A idustrial hygiee professioal will use available workplace ad laboratory iformatio to estimate how ofte tubes must be chaged. Aother possible problem is iterferece from other chemical substaces i the air. If other chemicals will also be used, it is ecessary to determie whether they could affect the results. Historically, substaces such as isopropyl alcohol, Freo 12, ad certai other oxides have iterfered with some ethylee oxide aalytical methods. Note other possible chemical substaces that could be preset i your workplace ad discuss them with the laboratory that will aalyze your samples. This step will

help to determie whether a iterferece could exist ad to idetify a appropriate samplig strategy. You may wish to obtai professioal advice to address these issues. Cosult a idustrial hygieist to get help plaig a samplig procedure that is suitable for your workplace. Professioal advice may save you time ad effort. It ca also icrease your cofidece that the resources you exped o samplig ad aalysis will provide you with valid results. See Sectio 5.E - How to Obtai Further Assistace. Preparig the equipmet ad collectig samples Excerpt: OSHA s Samplig ad Aalytical Method 50 OSHA s Samplig ad Aalytical Method 50 Ethylee Oxide, Sectios 2.1 ad 2.3, www.osha.gov/dts/sltc/ methods/orgaic/org050/org050.html provide the followig istructios for usig a air samplig pump ad sorbet tube (Figures 1 through 12 o the ext pages illustrate key poits): 2.1. Apparatus 2.1.1. A costat flow persoal samplig pump is used which ca be calibrated to withi ±5% of the recommeded 0.1 L/mi flow rate while the samplig trai is i lie. See Figures 1-6. 2.3. Techique 2.3.1. Properly label the samplig tube before samplig. See Figure 7. 2.3.2. Attach the samplig tube to the pump usig a sectio of flexible, plastic tubig such that the large, frot sectio of the sample tube is exposed directly to the atmosphere. Do ot place ay tubig i frot of the samplig tube. The samplig tube should be attached i the worker s breathig zoe vertically such that it does ot impede work performace. See Figures 8 ad 9. 2.3.3. After samplig for the appropriate time, remove the samplig tube from the pump, replace the plastic caps ad seal the tube with a official seal. See Figure 10. 2.3.4. Iclude at least oe blak for each samplig set. The blak should be hadled i the same maer as the samples with the exceptio that air is ot draw through it. See Figure 11. 2.3.5. List ay potetial iterfereces o the sample data sheet. See Figure 12. 49 Sectio 5

Figure 1: Select a persoal air samplig pump that provides a suitable rage of air flow rates. The pump show here requires a special added lowflow valve to adjust the air flow rate to the correct level for samplig EtO, which is 100 milliliters of air per miute (ml/mi) or the equivalet of 0.100 liters per miute (l/mi). Sectio 5 50

Figure 2: Commuicate with the aalytical laboratory to select a appropriate sorbet tube for the situatio to be moitored. Sorbet tubes come i several sizes, which may appear similar to, but ot ecessarily idetical to the tube show here. Figure 3: Tubes usually arrive i a evelope, alog with caps for sealig the tube after air samplig is completed. 51 Sectio 5

Figure 4: Just before usig a tube, use a commercially available tube breaker (left) or pliers (right) to getly break the glass tip off each ed of the tube so that air ca flow through it. As a rule of thumb, break the tip at a poit that will make a opeig about half the diameter of the tube body. Check that both eds of the tube are ope improperly opeed tubes will cause the air samplig effort to fail. Sectio 5 52

Figure 5: While breakig the glass, wear safety glasses ad hold the tube i a box or trash receptacle. Hadle the tube with care to avoid ijury. The broke glass tips ca be sharp. 53 Sectio 5

Directio of Air Flow Direct i o of A F ir low Sorbet Tube Cap removed from air flow meter ilet ad outlet ports { Attach so the arrow prited o the tube is poited i the directio of the plastic tubig leadig to the pump Persoal Air Samplig Pump io ect Dir { of Air Flow (to ward pump) } Low-flow Adaptor (for use with certai pump models) Low Airflow Adapter Adjustmet Screw Figure 6: The pump must be calibrated to adjust the air flow to the correct flow rate. A wide variety of flow meters are commercially available ad oe should be used to cofirm the rate of air flow before ad after each samplig sessio. Durig calibratio, air flow through older pump models is adjusted usig a set screw, while some recet models may be programmed electroically. These calibratio tests must always be performed with a sorbet tube, of the same model as that used for samplig, placed i-lie betwee the pump ad the flow meter. Hit: Order a extra sorbet tube to use for pump calibratio. This calibratio tube is ever set to the laboratory for aalysis. Sectio 5 54

Figure 7: Wrap a strip label aroud the tube ad prit the sample umber o the label. Iclude ay additioal iformatio eeded to track the sample. Eter this umber ad relevat iformatio about the sample o a samplig form ad a log book (date, work locatio, employee ame, job title/activities, cotamiat beig sampled, ame of perso performig the samplig). Before you begi samplig, talk to employees so that they uderstad the process. Provide adequate advace otice to allow employees or their represetatives to observe the moitorig if they wish. 55 Sectio 5

Figure 8: Attach the pump to a belt at the employee s hip. Isert the sorbet tube i a commercially available tube holder or similar device ad clip it i the area of the employee s lapel, with the sorbet tube hagig dow. Figure 9: Air samplig professioals ofte use duct tape to hold excess plastic tubig i place so that it will ot get i the employee s way. Provide adequate slack i the plastic tubig to allow the employee to reach ad bed. For each sorbet tube used, eter o the samplig form the time that samplig starts with that tube. Tur the pump ON ad check periodically to be sure that it is ruig smoothly. Use a fully charged pump battery to esure that the pump will ru for the full samplig period. Sectio 5 56

Figure 10: Whe it is time to remove a sorbet tube from the pump, mark the sample form with the time that samplig with that tube stopped (if samplig cotiues with aother tube, also mark the start time for the ew tube). Next, place a cap o either ed of the sorbet tube to make it airtight. The, if desired, fold the tube ad its label i a strip of paper (blue i the photo series above) ad seal the edges of the paper with tape to create a tamper-resistat seal. Mark the outside of the sealed sorbet tube with its origial label umber ad other idetifyig iformatio requested by the laboratory (e.g., compay ame, date, security seal ad sigature). May samples, icludig most ethylee oxide samples, ca be placed i a plastic zip bag, wrapped i paddig, ad shipped to the laboratory i a rigid (crushproof) box. Some types of samples, however, require refrigeratio or require you to avoid some packagig materials that might cotamiate the sample. To be certai, ask the aalytical laboratory whether your sample eeds ay special hadlig. 57 Figure 11: For quality cotrol purposes, the laboratory will request at least oe blak sample per group of sorbet tubes submitted for aalysis. A blak sample is a sorbet tube of the same lot umber as the tubes used to coduct the air moitorig. The blak tube should be opeed (tube tips broke off), but o air should be draw through it (do ot coect the blak sorbet tube to a pump). Label ad seal the blak sorbet tube i the same maer as the other samples. Issue the blak sample a umber as if it were a air sample; however, istead of otig the pump flow rate ad sample time, write BLANK o the sample form. Figure 12: Record sample iformatio ad otes to the laboratory o the sample data sheet. Sectio 5

For more iformatio o exposure moitorig for employees, see Sectio 6.B - Coductig Persoal Moitorig. Retur to Sectio 2.A.ii.a - Persoal Moitorig. If the laboratory directs you to ship a sample o ice or uder refrigeratio, you ca put the sample i a rigid, compact ice chest (as show) ad add a freezer pack to ship the sample usig a overight express service. Use care i packig the sample to prevet it from beig battered by the freezer pack if the ice chest receives rough hadlig i trasit. Sectio 5 58

M. Compariso of Passive Dosimeters ad Traditioal Air Samplig Methods Usig a Pump ad Sorbet Tube Cosideratio Passive dosimeter Persoal air samplig pump ad sorbet tube Alterate ames Passive Dosimeter Passive Diffusio Moitor Persoal Moitorig Badge Passive (Diffusive or Diffusio) Sampler Sorbet Tube Charcoal Tube Coated/treated Charcoal Tube Ease of use Accuracy of results Easy to use uder routie coditios, icludig 8-hour samplig sessios with exposures i the rage of the PEL or lower, or 15-miute sessios of exposure i the rage of the excursio limit or lower. Uder other circumstaces, special calculatios may be required to determie whether ad how passive dosimeters should be used. Natural air currets might ot be adequate to esure reliable samplig. Results might be affected if the dosimeter is placed i a area with poor air circulatio (such as i a corer or ext to a wall). Whe routie samplig is coducted correctly ad aalysis is performed by a qualified laboratory, results typically meet OSHA accuracy requiremets. 59 Requires some traiig ad experiece to obtai reliable results. Additioally, a sample pla should be developed i advace to evaluate task ad shift duratio, aticipated exposure levels, ad sorbet tube capacity. These factors determie whether ad how ofte tubes eed to be chaged durig the samplig sessio. A air samplig pump allows more cotrol over the samplig process, ad, therefore, produces more reliable results uder a wider rage of coditios (e.g., durig irregular work shifts, short samplig periods, periods of high exposure levels, ad locatios with poor air circulatio). Uder these coditios, results obtaied with a pump may be more accurate ad precise tha results obtaied usig a passive dosimeter. Whe samplig is coducted correctly ad aalysis is performed by a qualified laboratory, results typically meet OSHA accuracy requiremets. Sectio 5

Cosideratio Passive dosimeter Persoal air samplig pump ad sorbet tube Cost of samplig media (ot icludig aalysis). Cost of aalysis (may iclude samplig media ad other optios). Cost of additioal equipmet. Chemicals that ca be moitored. Iterfereces Cost more tha sorbet tubes (i the rage of $20 to $25 per passive dosimeter). Cost less tha passive dosimeters (usually less tha $5 per sorbet tube). Variable depedig o how quickly results are eeded. Cost of aalysis is similar for these two types of media (passive dosimeter ad sorbet tube). No additioal equipmet required. Passive dosimeter models are commercially available for a limited but growig umber of airbore vapors. Check with your aalytical laboratory. Ca be affected by temperature, humidity, ad the presece of other chemical substaces. Discuss your situatio with the aalytical laboratory. Retur to Sectio 2.A.ii.a - Persoal Moitorig. A air samplig pump ad pump calibratio equipmet are required ad ca cost hudreds of dollars each. However, pump retal or loa is sometimes icluded i the cost of the samplig ad aalysis. Check with a idustrial hygieist or aalytical laboratory. Maufacturers offer a selectio of sorbet tubes appropriate for moitorig a wide rage of airbore vapors. Check with your aalytical laboratory. Ca be affected by temperature, humidity, ad the presece of other chemical substaces. Discuss your situatio with the aalytical laboratory. See Sectio 6 - Related OSHA Stadards ad Other Helpful Resources. Sectio 5 60

6. Related OSHA Stadards ad Other Helpful Resources A. Ethylee Oxide - Geeral OSHA Stadard Ethylee Oxide: 29 CFR 1910.1047 This is the stadard that lists the OSHA requiremets for ethylee oxide i the workplace. This website also icludes direct liks to the appedices associated with OSHA s EtO stadard. www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_id=10070 NIOSH Health ad Safety Topic Page for Ethylee Oxide This website provides liks to several NIOSH publicatios o topics related to employee exposure to ethylee oxide (e.g., laboratory aalytical methods, NIOSH Alerts, employee otificatio iformatio). Some of these documets are quite techical, while others are iteded for employees ad their supervisors. www.cdc.gov/iosh/topics/ethyleeoxide Example of a Ethylee Oxide Maagemet Pla The Medical Uiversity of South Carolia Ethylee Oxide Maagemet Pla is oe example of a EtO maagemet pla. The pla outlies how the uiversity complies with the requiremets of OSHA s EtO stadard ad lists the work practices used by employees at the uiversity to help keep exposures below the actio level. www.musc.edu/fada/risk/osha/safetymaual2005/ethylee.pdf#search= %22Ethylee%20Oxide%20Safety%20pla%22 61 Sectio 6

State of Washigto Ethylee Oxide Stadard (Chapter 296-855, WAC, Jauary 2006) This documet presets Washigto State s EtO stadard. Because Washigto is a OSHA State Pla State, this stadard is at least as protective as Federal OSHA s EtO stadard ad may of the provisios are idetical, although the Washigto State stadard may also iclude additioal provisios ot foud i the federal stadard. The Washigto EtO stadard applies oly i Washigto; however, eve if employers do ot have facilities i Washigto, some may fid the user-friedly presetatio style of the Washigto State stadard helpful. www.li.wa.gov/wisha/rules/ethylee/pdfs/296-855complete.pdf Retur to Sectio 1 - Overview. B. Coductig Persoal Moitorig OSHA Techical Maual Persoal Samplig for Air Cotamiats (Sectio II, Chapter 1) This chapter of the maual for OSHA persoel provides basic istructios o performig persoal air moitorig. It covers geeral procedures, sample media, istrumet preparatio ad calibratio, ad a discussio of samplig ad aalytical error. Although the maual is iteded for OSHA persoel ad lists forms ad sample shippig istructios specific to OSHA, the chapter provides a good overview of the air samplig process. Ayoe plaig to coduct air samplig should cotact their aalytical laboratory of choice before ay moitorig is performed. This step is importat to coordiate the choice of methods ad samplig media. http://www.osha.gov/dts/osta/otm/otm_ii/otm_ii_1.html Sectio 6 62

3M Air Moitorig Systems (Documet 4026) Simple illustratios o the first page of this 2-page documet show how to attach a passive dosimeter to the collar i the employee s breathig zoe. The guide also lists dosimeter accuracy iformatio. Dosimeter placemet iformatio cotaied i this guide applies to all types of passive dosimeters. Employers coductig air samplig, however, should esure that they obtai accuracy iformatio from the supplier for the specific brad of dosimeters they use. The accuracy must meet OSHA s miimum requiremets of 95 percet ± 25 percet (for 1 ppm samples) or ± 35 percet (for 0.5 ppm or for 15-miute excursio samples) as discussed i Sectio 5.B. 3M Techical Data Bulleti #1028 Orgaic Vapor Moitor Samplig ad Aalysis Guide This 11-page techical publicatio provides geeral backgroud iformatio o the use of passive dosimeters for samplig uder a variety of circumstaces. Although ot specific to ethylee oxide, it itroduces relevat topics such as homogeeous exposure groups (HEG), moitor capacity, laboratory aalysis procedure, recovery coefficiets, ad work shifts that are ot 8 hours. http://multimedia.mmm.com/mws/mediawebserver.dy?6666660zjcf6lvs6evs6667mccorrrrq- http://multimedia.mmm.com/mws/mediawebserver.dy?6666660zjcf6lvs6evs666cswcorrrrq- 63 Sectio 6

3M Air Moitorig Guide (for passive dosimeters icludig models 3550/3551 for ethylee oxide) This guide provides detailed illustrated istructios for usig passive dosimeters for persoal ad area moitorig. The moitorig istructios apply to all passive dosimeters, but the dosimeter preparatio istructios apply specifically to 3M moitors (icludig those for ethylee oxide). Although the examples i this guide refer to specific models of 3M equipmet, you may substitute other equivalet equipmet made by other maufacturers; however, you should cosult with your supplier for dosimeter preparatio istructios for the specific model you use. http://multimedia.mmm.com/mws/mediawebserver.dy?6666660zjcf6lvs6evs666mfpcorrrrq- SKC Passive (Diffusive) Samples A cross-sectioal view iside a passive dosimeter ad illustrated istructios for usig passive dosimeters for persoal moitorig. Although the examples i this guide refer to specific models of SKC equipmet, you may substitute other equivalet equipmet made by other maufacturers; however, you should cosult with your supplier for dosimeter preparatio istructios for the specific model you use. www.skcic.com/prod/575-001.asp SKC Applicatio Guide: Samplig Trai - Sorbet Samplig Tubes www.skcic.com/istructios/1168.pdf Sectio 6 64 This documet describes the process for collectig persoal exposure samples usig a air samplig pump ad sorbet tubes (oe of the ways to coduct persoal moitorig). The istructios illustrate how to coect the sorbet tube to the pump ad where to attach both of these items to the employee. Special ote: although the examples i this guide refer to specific models of equipmet, you may substitute other equivalet equipmet made by other maufacturers.

Ethylee Oxide OSHA 50 (SKC chemical fact file) This documet icludes air flow rate, sample time, ad air volume for collectig a persoal moitorig sample for ethylee oxide usig a sorbet tube ad persoal air samplig pump. It also outlies the steps for hadlig a sorbet tube ad pump. This specifically targeted 1-page fact sheet is adapted from the 21-page OSHA Method 50 for laboratory aalysis of ethylee oxide samples. Although the examples i this guide refer to specific models of equipmet, you may substitute other equivalet equipmet made by other maufacturers. www.skcic.com/cff/1014.pdf OSHA Samplig ad Aalytical Method 50 (sorbet tube method) This highly techical 21-page documet cotais detailed iformatio o laboratory aalysis of ethylee oxide. It cotais istructios for usig a sorbet tube ad air samplig pump; however, most small busiess employers might prefer to get the same iformatio i summary form by requestig istructios from their aalytical laboratory of choice. www.osha.gov/dts/sltc/methods/orgaic/org050/org050.html SKC Applicatio Guide: Calibratig a Pump Usig a Electroic Calibrator (Pub 1014 rev 208) This 2-page guide provides detailed illustrated istructios for usig a electroic flow meter to calibrate a persoal air samplig pump fitted with a sorbet tube. Although the examples i this guide refer to specific models of equipmet, you may substitute other comparable equipmet made by other maufacturers. www.skcic.com/istructios/1366.pdf 65 Sectio 6

OSHA Samplig ad Aalytical Method 49 (passive dosimeter method) This highly techical 16-page documet cotais detailed iformatio o laboratory aalysis of ethylee oxide moitors. It cotais istructios for usig a passive dosimeter; however, most small busiess employers might prefer to get the same iformatio i summary form by requestig istructios from their aalytical laboratory of choice. www.osha.gov/dts/sltc/methods/orgaic/org049/org049.html Retur to Sectio 5.K - Passive Diffusio Dosimeter. Sectio 6 66

The metio of ay istrumet provider, product, or process i this publicatio does ot costitute or imply edorsemet by the Occupatioal Safety ad Health Admiistratio. This list is ot meat or able to be comprehesive, as there may be other suppliers that have ot bee brought to our attetio. Suppliers of passive diffusio dosimeters/moitors for ethylee oxide moitorig Assay Techology, Pleasato, CA. Tel: 800-833-1281. SKC Ic., Eighty Four, PA. Tel: 800-752-8472. www.skcic.com 3M, St. Paul, MN. Tel: 800-869-4223. www.3m.com/occsafety Suppliers of sorbet tubes suitable for ethylee oxide moitorig Assay Techology, Pleasato, CA. Tel: 800-833-1281. SKC Ic., Eighty Four, PA. Tel: 800-752-8472. www.skcic.com Supelco (Sigma-Aldrich Group) St. Louis, MO. Tel: 800-247-6628. www.sigmaaldrich.com Suppliers of low-flow persoal air samplig pumps suitable for ethylee oxide moitorig (100 ml/miute flow rate) A.P. Buck Ic. Orlado, FL. Tel: 800-330-2825. www.apbuck.com Sesidye (Gillia pumps), Clearwater, FL. Tel: 800-451- 9444. www.sesidye.com SKC Ic., Eighty Four, PA. Tel: 800-752-8472. www.skcic.com TSI Ic. Shoreview, MN. Tel: 800-874-2811. www.tsi.com Other sources of samplig istrumets ad media: Some aalytical laboratories will loa pumps ad provide sample media as part of the aalytical fee. Alteratively, you may ret or lease air samplig pumps ad gas detectio equipmet from laboratories ad techical equipmet retal agecies (for example, coduct a Iteret search for ret persoal air samplig pump ). If you use a idustrial hygiee cosultat, that professioal will likely arrage to have all the ecessary equipmet ad supplies available. Retur to Sectio 5.K - Passive Diffusio Dosimeter (or Moitor). Retur to Sectio 5.L - Air Samplig Pump ad Sorbet Tube. 67 Sectio 6

C. Respiratory Protectio ad Persoal Protective Equipmet OSHA Stadard Respiratory Protectio: 29 CFR 1910.134 This is the stadard that lists the OSHA requiremets for respiratory protectio. www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_id=12716 OSHA Booklet Small Etity Compliace Guide for the Revised Respiratory Protectio Stadard (OSHA 9071), 1998 This documet provides geeral iformatio about respiratory protectio i the workplace ad OSHA s Respiratory Protectio stadard. The guide is iteded to assist small busiess employers to set up a respiratory protectio program. www.osha.gov/publicatios/secgrev-curret.pdf OSHA s Respiratory Protectio etool The purpose of this etool is to help you comply with the OSHA Respiratory Protectio stadard. It provides istructio o the proper selectio of respiratory protectio. www.osha.gov/sltc/etools/respiratory/idex.html OSHA Stadard Persoal Protective Equipmet Geeral Requiremets: 29 CFR 1910.132 This is the stadard that requires employers to perform a hazard assessmet to determie what PPE employees eed. It also requires that employees be traied to use the PPE ad that the PPE fits the employee. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_ id=9777 Sectio 6 68

OSHA Booklet Persoal Protective Equipmet (OSHA 3151), 2003 This OSHA guide reviews procedures for determiig what PPE is required to protect employees ad discusses OSHA requiremets for traiig employees to use the PPE correctly. To help employers evaluate the eed for PPE, the guide icludes select questios to ask about the jobs employees perform. http://www.osha.gov/publicatios/osha3151.pdf OSHA Letter of Iterpretatio Requiremets uder the Ethylee Oxide Stadard This is the letter OSHA provided i respose to a questio about whether EtO-equipmet service persoel must be issued PPE ad respirators if they visit workplaces where ethylee oxide is used. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_ table=interpretations&p_id=21749 Retur to Sectio 3.D - Provide Respiratory Protectio. D. Exposure Cotrol Ethylee Oxide Sterilizers i Health Care Facilities: Egieerig Cotrols ad Work Practices This lik provides iformatio o accessig NIOSH Curret Itelligece Bulleti-52 (1989, July 13), 15 pages, which describes exposure cotrol methods for sterilizers. http://www.cdc.gov/iosh/89115_52.html 69 Sectio 6

OSHA Letter of Iterpretatio Procedures for Ethylee Oxide (EtO) Spills ad Ethylee Oxide Disposal This is the letter OSHA provided i respose to a questio about the procedures for hadlig material durig EtO spill cleaup. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_ table=interpretations&p_id=19343 Retur to Sectio 3.C - Reduce Exposures with Egieerig Cotrols or Other Methods. E. Hazard Commuicatio Sectio 6 70 OSHA Stadard Hazard Commuicatio: 29 CFR 1910.1200 This is OSHA s regulatio o providig iformatio to employees who might be exposed to hazardous substaces (ot just EtO) i the workplace. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_ id=10099 OSHA Safety ad Health Topics Hazard Commuicatio This website provides liks to resources that are useful for employers developig or updatig a hazard commuicatio program. Amog the listigs at this site, you will fid dowloadable software developed for the Mie Safety ad Health Admiistratio ad iteded to help those resposible for writig a OSHA hazard commuicatio program; a self-ispectio checklist; ad a sample olie HazCom traiig program developed by the state of Orego. http://www.osha.gov/sltc/hazardcommuicatios/solutios.html

Ethylee Oxide Traiig Program This editable traiig program from the Washigto State Departmet of Labor ad Idustries is available at o charge i PDF or PowerPoit formats for use i employee educatio. The website also icludes a script. Both the presetatio ad script may be dowloaded ad customized to reflect the situatio i the area where employees work. http://www.li.wa.gov/safety/traitools/traier/kits/ethyleeoxide/default.asp Sample Hazard Commuicatio Program This is a program from the Divisio of Safety, Florida Departmet of Labor ad Employmet Security. Employers may customize this model hazard commuicatio program to create a program for their ow worksites. http://www.cdc.gov/elcosh/docs/d0300/d000384/d000384.html Ethylee Oxide (EtO) Fact Sheet From the Califoria Departmet of Public Health, this 6-page fact sheet (updated 1999) icludes iformatio that could be used as part of a employee commuicatio ad traiig program. http://www.dhs.ca.gov/ohb/hesis/eto.htm#tests_for_exposure_and_medical_tests 71 Sectio 6

NIOSH Worker Notificatio o Sterilizatio of Medical Istrumets ad Treatmet of Spices (Ethylee Oxide). April 2004 This summary report describes the results of a study of employees who were exposed to EtO while workig at sterilizatio plats. The study was coducted to determie if exposure to EtO is associated with cacer ad other diseases. http://www.cdc.gov/iosh/pgms/workotify/ethyleeoxide.html Retur to Sectio 4.A.i. - Hazard Commuicatio. F. Work Practices Prevetig Worker Ijuries ad Death from Explosios i Idustrial Ethylee Oxide Sterilizatio Facilities NIOSH Alert, NIOSH Pub: 2007-164, Revised Editio. (August 2007) This documet describes several accidets at sterilizatio facilities ad suggests work practices ad cotrols to improve safety. http://www.cdc.gov/iosh/docs/2007-164 Ethylee Oxide Hadlig This guide describes safe hadlig practices for uloadig, hadlig, ad storig EtO drums. http://www.balchem.com/images/pdfs/eohadligguide.pdf Retur to Sectio 3.C - Reduce Exposures with Egieerig Cotrols or Other Methods. Sectio 6 72

G. Medical Moitorig OSHA Stadard Access to Employee Exposure ad Medical Records: 29 CFR 1910.1020 This is OSHA s stadard describig what medical ad exposure records you must keep ad how log you must keep them. It also lists requiremets for keepig employee medical records cofidetial ad for providig copies of these records to employees ad idividuals desigated to represet them. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_ id=10027 OSHA Booklet Access to Medical ad Exposure Records (OSHA 3110), 2001 This is a easy-to-read summary of the OSHA stadard o the same topic. It is iteded for employers ad their employees. http://www.osha.gov/publicatios/osha3110.pdf OSHA Letter of Iterpretatio The Iterpretatio of the Medical Examiatios ad Cosultatios for Employees Who are Hired for Areas That Have Ethylee Oxide. August 7, 1995. This is the letter OSHA provided i respose to a questio about what testig is required for medical surveillace examiatios ad how iitial ad yearly exams differ from exams coducted i respose to a exposure. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_ table=interpretations&p_id=21877 Retur to Sectio 4.B - Medical Surveillace. 73 Sectio 6

H. Emergecy Plaig ad Alert Systems OSHA Stadard Emergecy Actio Plas: 29 CFR 1910.38 This OSHA stadard lists the miimum requiremets for a employer s emergecy actio pla. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_ id=9726 OSHA Stadard Fire Prevetio Plas: 29 CFR 1910.39 This OSHA stadard describes the miimum elemets that must appear i a employer s fire prevetio pla. http://www.osha.gov/pls/oshaweb/owadisp.show_documet?p_table=standards&p_ id=12887 Emergecy Respose Guide (ERG) 119 Ethylee Oxide (Applicable to ethylee oxide) This etry from the U.S. Departmet of Trasportatio (U.S. DOT) provides basic iformatio o respodig to a large release of EtO (e.g., hazards, evacuatio, spill ad leak cotrol procedures). Most iformatio is also applicable to smaller releases. http://hazmat.dot.gov/pubs/erg/g119.pdf Ethylee Oxide Sterilizer Alarm Systems This sectio, from the U.S. Joit Services Pollutio Opportuity Hadbook (updated 2003) discusses characteristics of commercially available ethylee oxide alarm systems ad provides iformatio from two maufacturers. http://p2sustaiabilitylibrary.mil/p2_opportuity_hadbook/3_vii_2.html Sectio 6 74

The metio of ay istrumet provider, product, or process i this publicatio does ot costitute or imply edorsemet by the Occupatioal Safety ad Health Admiistratio. This list is ot iteded or able to be comprehesive, as there may be suppliers who have ot bee brought to our attetio. Suppliers of hadheld ad/or fixed positio leak detectors ad alarm systems for EtO America Gas & Chemical Co., Ltd., Northvale, NJ. Tel. 1-800-288-3647 Aderso Products, Haw River, NC. Tel. 800-523-1276 Dräger Safety, Ic., Pittsburgh, PA. Tel: 1-800-858-1737 BW Techologies, Arligto, TX. Tel: 888-749-8878 Itersca Corporatio, Chatsworth, CA. Tel: 800-458-6153 Sierra Moitor Corporatio, Milpitas, CA. Tel: 408-262-6611 U.S. Idustrial Products, Cyprus, CA. Tel: 714-220-1829 Retur to Sectio 3.A.iii - Emergecy Alert Provisio. 75 Sectio 6

I. Geeral Occupatioal Safety ad Health Maagemet for Small Busiesses OSHA Booklet Small Busiess Hadbook (OSHA 2209), 2005 This documet icludes a brief descriptio of employers resposibilities for workplace safety ad health. The documet icludes checklists to help employers coduct a self-ispectio. http://www.osha.gov/publicatios/smallbusiess/small-busiess.pdf OSHA Hospital etool Cetral Supply Module The etool offers backgroud iformatio o various hazards (icludig EtO) that employees might ecouter i the area of a hospital where istrumets are sterilized - typically the cetral supply departmet. http://www.osha.gov/sltc/etools/hospital/cetral/cetral.html OSHA Cosultatio Program This program offers free ad cofidetial advice to small ad medium-sized busiesses i all states, with priority give to high-hazard worksites. Employers ca fid out about potetial hazards at their worksites ad improve their occupatioal safety ad health maagemet systems. http://www.osha.gov/dcsp/smallbusiess/cosult.html Sectio 6 76

7. Refereces LaMotage, AD, et al. 1990. Ethylee Oxide Health & Safety Maual: Traiig ad Referece Materials o the Safe Use of Ethylee Oxide i Sterilizig Equipmet. Secod Editio. (OSHA Docket H200C, exhibit 2-9-L). LaMotage, AD, ad Kelsey, MD. 1998. OSHA s Reewed Madate for Regulatory Flexibility: I Support of the 1984 Ethylee Oxide Stadard. America Joural of Idustrial Medicie. 34: 95-104. LaMotage, AD, Oakes, JM, ad Lopez, RN. 2004. Log-Term Ethylee Oxide Exposure Treds i U.S. Hospitals: Relatioship with OSHA Regulatory ad Eforcemet Actios. America Joural76 of Public Health. 94: (9), 1614-1619. NIOSH. 1989. Techical Report: Cotrol Techology for Ethylee Oxide Sterilizatio i Hospitals. Report No. 89-120. Natioal Istitute for Occupatioal Safety ad Health. 89-120.pdf (179 pages). (Accessed September 17, 2005.) http://www.cdc.gov/iosh/pdfs/89-120.pdf NIOSH. 2006. Ethylee Oxide - Registry of Toxic Effects of Chemical Substaces (RTECS). Natioal Istitute for Occupatioal Safety ad Health (NIOSH). (Accessed September 21, 2006.) http://www.cdc.gov/iosh/rtecs/kx256250.html#l 77 Sectio 7

8. OSHA Assistace OSHA ca provide extesive help through a variety of programs, icludig techical assistace about effective safety ad health programs, state plas, workplace cosultatios, ad traiig ad educatio. Safety ad Health Maagemet System Guidelies Effective maagemet of worker safety ad health protectio is a decisive factor i reducig the extet ad severity of work-related ijuries ad illesses ad their related costs. I fact, a effective safety ad health maagemet system forms the basis of good worker protectio, ca save time ad moey, icrease productivity ad reduce employee ijuries, illesses ad related workers compesatio costs. To assist employers ad workers i developig effective safety ad health maagemet system, OSHA published recommeded Safety ad Health Program Maagemet Guidelies (54 Federal Register (16): 3904-3916, Jauary 26, 1989). These volutary guidelies ca be applied to all places of employmet covered by OSHA. The guidelies idetify four geeral elemets critical to the developmet of a successful safety ad health maagemet system: Maagemet leadership ad employee ivolvemet, Worksite aalysis, Hazard prevetio ad cotrol, ad Safety ad health traiig. The guidelies recommed specific actios, uder each of these geeral elemets, to achieve a effective safety ad health maagemet system. The Federal Register otice is available olie at www.osha.gov. State Programs The Occupatioal Safety ad Health Act of 1970 (OSH Act) ecourages states to develop ad operate their ow job safety ad health plas. OSHA approves ad moitors these plas. Twety-four states, Puerto Rico ad the Virgi Islads curretly operate approved state plas: 22 cover both private ad public (state ad local govermet) employmet; Coecticut, New Jersey, New York ad the Virgi Islads cover the public sector oly. States ad territories with their ow OSHA-approved occupatioal safety ad health plas must adopt stadards idetical to, or at least as effective as, the Federal OSHA stadards. Cosultatio Services Cosultatio assistace is available o request to employers who wat help i establishig ad maitaiig a safe ad healthful workplace. Largely fuded by OSHA, the service is provided at o cost to the employer. Primarily developed for smaller employers with more hazardous operatios, the cosultatio service is delivered by state govermets employig professioal safety ad health cosultats. Comprehesive assistace icludes a appraisal of all mechaical systems, work practices, ad occupatioal safety ad health hazards of the workplace ad all aspects of the employer s preset job safety ad health program. I additio, the service offers assistace to employers i developig ad imple- Sectio 8 78

metig a effective safety ad health program. No pealties are proposed or citatios issued for hazards idetified by the cosultat. OSHA provides cosultatio assistace to the employer with the assurace that his or her ame ad firm ad ay iformatio about the workplace will ot be routiely reported to OSHA eforcemet staff. For more iformatio cocerig cosultatio assistace, see OSHA s website at www.osha.gov. Strategic Partership Program OSHA s Strategic Partership Program helps ecourage, assist ad recogize the efforts of parters to elimiate serious workplace hazards ad achieve a high level of worker safety ad health. Most strategic parterships seek to have a broad impact by buildig cooperative relatioships with groups of employers ad workers. These parterships are volutary relatioships betwee OSHA, employers, worker represetatives, ad others (e.g., trade uios, trade ad professioal associatios, uiversities, ad other govermet agecies). For more iformatio o this ad other agecy programs, cotact your earest OSHA office, or visit OSHA s website at www.osha.gov. OSHA Traiig ad Educatio OSHA area offices offer a variety of iformatio services, such as techical advice, publicatios, audiovisual aids ad speakers for special egagemets. OSHA s Traiig Istitute i Arligto Heights, IL, provides basic ad advaced courses i safety ad health for Federal ad state compliace officers, state cosultats, Federal agecy persoel, ad private sector employers, workers ad their represetatives. The OSHA Traiig Istitute also has established OSHA Traiig Istitute Educatio Ceters to address the icreased demad for its courses from the private sector ad from other federal agecies. These ceters are colleges, uiversities, ad oprofit orgaizatios that have bee selected after a competitio for participatio i the program. OSHA also provides fuds to oprofit orgaizatios, through grats, to coduct workplace traiig ad educatio i subjects where OSHA believes there is a lack of workplace traiig. Grats are awarded aually. For more iformatio o grats, traiig ad educatio, cotact the OSHA Traiig Istitute, Directorate of Traiig ad Educatio, 2020 South Arligto Heights Road, Arligto Heights, IL 60005, (847) 297-4810, or see Traiig o OSHA s website at www.osha.gov. For further iformatio o ay OSHA program, cotact your earest OSHA regioal office listed at the ed of this publicatio. Iformatio Available Electroically OSHA has a variety of materials ad tools available o its website at www.osha.gov. These iclude electroic tools, such as Safety ad Health Topics, etools, Expert Advisors; regulatios, directives ad publicatios; videos ad other iformatio for employers ad workers. OSHA s software programs ad etools walk you through challegig safety ad health issues ad commo problems to fid the best solutios for your workplace. 79 Sectio 8

OSHA Publicatios OSHA has a extesive publicatios program. For a listig of free items, visit OSHA s website at www.osha.gov or cotact the OSHA Publicatios Office, U.S. Departmet of Labor, 200 Costitutio Aveue, NW, N-3101, Washigto, DC 20210; telephoe (202) 693-1888 or fax to (202) 693-2498. Cotactig OSHA To report a emergecy, file a complait, or seek OSHA advice, assistace, or products, call (800) 321-OSHA or cotact your earest OSHA Regioal office listed at the ed of this publicatio. The teletypewriter (TTY) umber is (877) 889-5627. Writte correspodece ca be mailed to the earest OSHA Regioal or Area Office listed at the ed of this publicatio or to OSHA s atioal office at: U.S. Departmet of Labor, Occupatioal Safety ad Health Admiistratio, 200 Costitutio Aveue, N.W., Washigto, DC 20210. By visitig OSHA s website at www.osha.gov, you ca also: File a complait olie, Submit geeral iquiries about workplace safety ad health electroically, ad Fid more iformatio about OSHA ad occupatioal safety ad health. Sectio 8 80

9. OSHA Regioal Offices Regio I (CT,* ME, MA, NH, RI, VT*) JFK Federal Buildig, Room E340 Bosto, MA 02203 (617) 565-9860 Regio II (NJ,* NY,* PR,* VI*) 201 Varick Street, Room 670 New York, NY 10014 (212) 337-2378 Regio III (DE, DC, MD,* PA, VA,* WV) The Curtis Ceter 170 S. Idepedece Mall West Suite 740 West Philadelphia, PA 19106-3309 (215) 861-4900 Regio IV (AL, FL, GA, KY,* MS, NC,* SC,* TN*) 61 Forsyth Street, SW, Room 6T50 Atlata, GA 30303 (404) 562-2300 Regio V (ll, IN,* MI,* MN,* OH, WI) 230 South Dearbor Street Room 3244 Chicago, IL 60604 (312) 353-2220 Regio VI (AR, LA, NM,* OK, TX) 525 Griffi Street, Room 602 Dallas, TX 75202 (972) 850-4145 Regio VII (IA,* KS, MO, NE) Two Pershig Square 2300 Mai Street, Suite 1010 Kasas City, MO 64108-2416 (816) 283-8745 Regio VIII (CO, MT, NO, SO, UT,* WY*) 1999 Broadway, Suite 1690 PO Box 46550 Dever, CO 80202-5716 (720) 264-6550 Regio IX (AZ,* CA,* HI,* NV,* ad America Samoa, Guam ad the Norther Mariaa Islads) 90 7th Street, Suite 18-100 Sa Fracisco, CA 94103 (415) 625-2547 Regio X (AK,* ID, OR,* WA*) 1111 Third Aveue, Suite 715 Seattle, WA 98101-3212 (206) 553-5930 * These states ad territories operate their ow OSHA-approved job safety ad health programs ad cover state ad local govermet employees as well as private sector employees. The Coecticut, New Jersey, New York ad Virgi Islads plas cover public employees oly. States with approved programs must have stadards that are idetical to, or at least as effective as, the Federal OSHA stadards. Note: To get cotact iformatio for OSHA Area Offices, OSHA-approved State Plas ad OSHA Cosultatio Projects, please visit us olie at www. osha.gov or call us at 1-800-321-0SHA. 81 Sectio 9