Hospitals: Ethylene Oxide Sterilizers - US Environmental Protection ...

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73614 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULESalternatives do not reflect what manysterilizers have achieved (using controltechnology) and are capable ofachieving cost effectively.Response: As previously mentioned,we are setting standards for hospitalsterilizer area sources based on GACT(i.e., generally available controltechnologies or management practices)pursuant to section 112(d)(5) of theCAA. As several commenters noted, themanagement practice for runningsterilizers with full loads will ensurethat hospitals sterilize the most numberof medical devices per pounds ofethylene oxide emitted. We believe thatthe comments indicating that themanagement practice is common sense,consistent with current operatingpractices at many hospitals, and costeffective,all support our determinationthat this management practicerepresents a generally availablemanagement practice that is used tocontrol ethylene oxide emissions fromarea source hospital sterilizers. We,therefore, disagree with the commentthat the management practicerequirement in this final rule is notconsistent with legal requirements. Inaddition, for a detailed discussion onEPA’s consideration of the existingcontrol technologies, please see sectionV.C of this preamble.2. Exemption of Certain Sources Fromthe RuleComment: One commenterrecommended that EPA excludecontrolled sources (i.e., sources withadd-on control) and sources that use anethylene oxide concentration of lessthan 10 percent from all requirementsassociated with Alternative 1 shouldEPA adopt that alternative. Thecommenter expressed that Alternative 1imposes no additional substantiverequirements on controlled sterilizersand would only add administrativeburdens with no additionalenvironmental benefits. The commenteralso asserted that sources that use anethylene oxide concentration of lessthan 10 percent can be excluded withno detrimental effect.Response: EPA disagrees that this rulecontains no substantive requirements oncontrolled sterilizers. As we clarify inthe final rule and in section III.B of thispreamble, all area source hospitalsterilizers, including sources with addoncontrols, are subject to therequirements in this final rule.However, the final rule provides certaincompliance options. Specifically, thefinal rule provides sources with add-oncontrols the option of demonstratingcompliance with the managementpractice requirement by certifying thatthey will continue to operate theirsterilizers with such control.EPA also rejects the recommendationof excluding from this rule sources thatuse an ethylene oxide concentration ofless than 10 percent. We recognize thatthere are hospital sterilization facilitiesthat use sterilant gas blends with lowethylene oxide concentrations.However, we have no informationsuggesting that facilities using lowethylene oxide sterilant gas blends emitnegligible amounts of ethylene oxide.On the contrary, it is our understandingthat there is little difference in theamount of ethylene oxide usage (and,therefore, ethylene oxide emissions)between operating a sterilization cyclewith pure ethylene oxide as opposed tousing sterilant gas blend with less than10 percent ethylene oxide. When welisted the Hospital Sterilizer AreaSource category, we included hospitalethylene oxide sterilization facilitiesusing sterilant gas blends and thecommenter did not provide anyinformation that suggests these facilitiesshould not be part of the sourcecategory. Further, we have analyzed thecosts and impacts associated with themanagement practice that we arefinalizing and we believe the costs arereasonable. See section V.C.1 of thispreamble. For the reasons stated above,we reject the commenter’srecommendation to exclude from thisregulation sources using sterilant gasblends with less than 10 percentethylene oxide concentration.3. Exception to the ManagementPractice RequirementComment: One commenter stated thatEPA would need to establish, based oncomments received and then proposeagain for comment, examples ofdefinitions of circumstances that wouldbe acceptable for an exemption to thefull load requirement. Anothercommenter observed that hospitals tryto minimize their use of ethylene oxideand avoid exceptions to full load runs.Although the commenter stated thatgenerating and managing an inclusivelist of all the exceptions to running afull load may be difficult, it providedexamples for such exceptions.Specifically, the commenter stated that,on some days, a hospital may receiveback from surgery just a few devices thatmust be ethylene oxide-sterilized andreturned as soon as possible to surgeryfor cases scheduled for the nextmorning. The commenter stated that, inthese instances, the hospital can beforced to run a sterilizer with less thana full load. The commenter also stressedthat hospital surgical needs can beunpredictable.VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1The commenter stated that hospitalshave reduced their use of ethylene oxideto sterilize medical devices (and itsethylene oxide emissions) by switchingto single-use devices or alternativesterilizing and disinfectiontechnologies, or by consolidatingethylene oxide sterilization. Thecommenter noted that, ironically, ahospital may increase the frequencywith which it needs to run a partiallyloaded ethylene oxide sterilizer as aresult. The commenter, however,emphasized that even with occasionalrunning of less than full loads, there hasbeen a continuing decline in hospitalethylene oxide use and emissions.Another commenter similarly notedthat hospitals currently strive to run fullloads unless it is medically necessary torun less than a full load. According tothe commenter, often the medicaldevices processed by the hospitalethylene oxide sterilizer are expensiveand hospitals can only afford to retaina minimal number of such devices. Thecommenter further noted that some ofthe devices are older devices and cannotbe replaced. The commenter stated thatthese devices are typically utilized insurgical areas and, at times, thesedevices may need to be used onconsecutive days. The commenter statedthat the ethylene oxide sterilizer load isprocessed at the end of the day so thedevices will be ready for surgery thefollowing day. According to thecommenter, by waiting to run asterilization cycle until the end of theday, the sterilizer load has a chance tofill up. The commenter noted, however,that if a medical device is needed thefollowing day, the load will beprocessed even though the load is notfull. The commenter stated that thedetermination to process a load is basedon the needs of the patient.Response: According to thecomments, hospitals deviate from thefull-load management practice onlywhen patient safety may be at risk. EPAagrees that medical necessity warrantsoperating a partially loaded ethyleneoxide sterilizer. To accommodatepatient needs, we have incorporated inthe final rule an exception based onmedical necessity.EPA also agrees with the commentthat developing a comprehensive list ofmedically necessary circumstanceswarranting sterilization of a partial loadis difficult. EPA is concerned that sucha list may inadvertently exclude somejustified circumstances. Further, asreflected in our final rule, we believethat the decision to run a partiallyloaded sterilizer due to medicalnecessity should be made by authorizedhospital personnel who have knowledge
Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73615pwalker on PROD1PC71 with RULESof patients’ medical needs instead of byEPA. However, to assure that hospitalsrun sterilizers in full loads exceptduring medically necessarycircumstances, the final rule requiresthat facilities document and maintainrecords of every sterilization cycle,including each partially loadedsterilization, and confirm that it wasmedically necessary.Comment: One commenter noted thatmany university hospitals develop newand unique surgical procedures anddevices that may need to be sterilized inpartial loads to comply with the morestringent requirements for sterilizing anew instrument.Response: We believe that it ismedically necessary to allow hospitalsto sterilize medical devices that areunder research and developmentwithout a full load. The novelty oruniqueness of the design in someinstances require different sterilizingparameters than those used for regularmedical devices. In addition, unlikemedical devices that are regularly usedfor patient care, new and experimentalmedical devices that are under researchand development do not haveestablished or known sterilizationcycles. Therefore, they may compromisethe effectiveness of sterilizing otherdevices in the same loads. However,hospitals generally do not possessenough medical devices that are underresearch and development to fully loada sterilizer. To avoid compromising thesterilization process of medical devicesregularly used for patient care, webelieve that it is medically necessary toallow hospitals to sterilize medicaldevices that are under research anddevelopment in separate and partialloads. <strong>Hospitals</strong> may invoke the medicalnecessity exception in the final rulewhen sterilizing devices that are underresearch and development.4. National or UrbanComment: Three commentersrecommended that EPA apply this rulenationwide. Two of the commentersnoted that hospital parking areas aretypically close to the hospital and thatvisitors and employees are, therefore,exposed to emissions from hospitalethylene oxide sterilizers regardless ofthe hospital’s location (i.e., urban orrural). One commenter stated that theimpacts of ethylene oxide emissions arelocalized and would be similar for mosturban and rural areas. According to thecommenter, hospitals are typicallylocated in residential areas, whether ornot they are in urban areas, and thatpopulations residing nearby wouldlikely be exposed to the ethylene oxideemissions from a hospital ethyleneoxide sterilization facility. Anothercommenter further stated that hospitalsclearly serve more sensitive populationswho could be more susceptible toimpacts from exposure to ethyleneoxide. The commenter similarly notedthat the impacts of ethylene oxideemissions are very local and would beroughly the same for both urban andrural areas, except perhaps for hospitalslocated in areas with a high populationdensity.Two commenters noted that the cost(of controlling a sterilizer) to a facilityis the same for a rural hospital and anurban hospital. The commenters statedthat, because the cost and impact are thesame, there does not appear to be anyrationale for treating rural hospitalsdifferently from urban hospitals.Response: We agree that a nationwideapproach is appropriate given the factsand circumstances of this particular areasource category. A rule of nationwideapplicability is particularly appropriatehere because requiring controlsnationwide provides for equitableemission reductions. Control costs arenot expected to differ in rural versusurban settings, therefore, the control’scost-effectiveness is the same, andeconomic impacts are equallydistributed. Furthermore, becausehospitals are generally located indensely populated areas, we expectnegligible difference in the scope of thisrule’s coverage between a national andan urban (i.e., Urban-1 and Urban-2areas) rule. 4 We have received nocomments recommending that we limitthis rule’s applicability only to hospitalsin Urban-1 and Urban-2 areas.5. Compliance DateComment: One commenter stated thatEPA’s proposal that a source complywith the management practices within 1year after the effective date of the finalrule may not be a sufficient period oftime. The commenter stated that twoscenarios could result for medicalfacilities under the managementpractice alternative. According to thecommenter, one scenario could be thatmedical facilities may need to purchasesmaller ethylene oxide sterilizers to turnaround medical instrumentation andequipment without having to purchasemore of these medical items, and this4 In the Integrated Urban Strategy, EPA defined‘‘urban areas’’ to include Urban-1 and Urban-2areas. (64 FR 38724). The Urban-1 and Urban-2definitions are based on the United States CensusBureau’s most current decennial census data.Urban-1 areas are counties with metropolitanstatistical areas with a population greater than250,000. Urban-2 counties are all other countieswhere more than 50 percent of the population isdesignated urban by the United States CensusBureau.VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1could involve construction projects/costs to make ready additional space toaccommodate the new sterilizers. Thecommenter stated that the otherscenario could be that medical facilitiesmay need to purchase additionalmedical instrumentation and equipmentto allow for sufficient availability whilewaiting for enough items to accumulateto run a full load in an ethylene oxidesterilizer. The commenter suggested thatEPA consider the costs of additionalethylene oxide sterilizer equipment andrelated construction, as well as theadditional medical instrumentation andequipment costs in any proposed ruleby EPA.Response: EPA does not believe thatthe management practice requirement inAlternative 1 will result in either of thescenarios described above. Themanagement practice requires sterilizingfull loads except during medicallynecessary circumstances, i.e., necessaryto protect human health. As discussedabove, this exception to runningsterilizers in full loads is based onpatient needs. Under the final rule,whether a medically necessarycircumstance exists must be determinedby an authorized hospital personnel.The final rule, however, requires onlythat the hospital personnel considerwhether sterilizing a partial load isnecessary to protect human health; thepersonnel are not required to considerwhether there are viable alternatives torunning a partial load, such aspurchasing additional sterilizerequipment or medical devices, beforeinvoking the exception to themanagement practice requirement.Therefore, we do not expect any needfor construction and/or capitalexpenditures associated with such newpurchases, as the commenter suggested.We have received no other commentssuggesting that hospitals may havedifficulty achieving compliance withthe management practice alternativewithin 1 year, as we proposed. We,therefore, retain the 1-year compliancedeadline in the final rule.6. RecordkeepingComment: In the proposed rule, EPAsolicited comments on whether torequire recordkeeping under Alternative1. We received six comments onrecordkeeping. One commenter askedthat EPA specify what recordkeepingwould entail if less than full loads wererun and what EPA would propose to bedone with these records. Anothercommenter stated that, regardless of thesize of the load, all items sterilized arerecorded following the Association forthe Advancement of MedicalInstrumentation standard, <strong>Ethylene</strong>
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