Occupational Safety and Health Act of 1970

Transcription

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2 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 ) 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

3 Small Busiess Guide for Ethylee Oxide U.S. Departmet of Labor Occupatioal Safety ad Health Admiistratio OSHA

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5 Cotets Cover photos: Getty Images, Washigto State OSHA, Natioal Istitute for Occupatioal Safety ad Health (NIOSH) 1. Overview 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 C. Actios Triggered by Air Sample Results D. How to Get Help with Air Moitorig Exposure Reductio/Prevetio A. Methods of Detectig Emergecy EtO Releases i. Emergecy Situatios ii. Emergecy Pla for EtO iii. Emergecy Alert Provisio B. Develop a Compliace Program C. Reduce Exposures with Egieerig Cotrols or Other Methods D. Provide Respiratory Protectio Other Requiremets A. Employee Iformatio ad Traiig i. Hazard Commuicatio ii. Establish Regulated Areas iii. Esure that Cautioary Labels are Fixed to Cotaiers iv. MSDS B. Medical Surveillace

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

7 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 ). 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

8 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

9 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

10 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

11 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

12 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 ( (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

13 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 OSHA or visitig 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

14 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.

15 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

16 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

17 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 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 ppm Fix exhaust vetilatio fa (by May 4). May ppm Adjust vetilatio suctio agle at machie door (by May 6 eveig). May ppm Retest air wait at least 7 days (but ot more tha 3 moths) to do test. May 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

18 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

19 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 D Provide iformatio ad traiig Yes Yes Yes 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 A.iii Yes Yes Not required 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

20 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 Sectio 2 16

21 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

22 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 ). 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

23 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 (g) util the emergecy is abated ad must be implemeted i accordace with 29 CFR , Respiratory Protectio. The pla must iclude the elemets cotaied i 29 CFR ad 29 CFR , 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 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

24 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

25 Persoal Protective Equipmet OSHA s geeral PPE requiremets (29 CFR , 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 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 , 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

26 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

27 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 (g). For assistace with respiratory protectio program requiremets, review OSHA s Respiratory Protectio stadard (29 CFR ) 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

28 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

29 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

30 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 Ethylee Oxide < 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 The label must also iclude a warig agaist breathig air cotamiated with EtO. Oe example of a suitable label at bottom left. 26

31 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

32 If a employee wears a respirator, OSHA s Respiratory Protectio stadard, 29 CFR , 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

33 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