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

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73611* * * * *[FR Doc. E7–24950 Filed 12–27–07; 8:45 am]BILLING CODE 6560–50–PENVIRONMENTAL PROTECTIONAGENCY40 CFR Part 63[EPA–HQ–OAR–2005–0171; FRL–8512–1]RIN 2060–AM14National Emission Standards forHospital Ethylene Oxide SterilizersAGENCY: Environmental ProtectionAgency (EPA).ACTION: Final rule.SUMMARY: EPA is issuing nationalemissions standards for new andexisting hospital sterilizers that emithazardous air pollutants and are areasources within the meaning of Clean AirAct section 112(a)(2). The final rule isbased on EPA’s determination as towhat constitutes the generally availablecontrol technology or managementpractices for the hospital sterilizer areasource category.This action is being finalized as partof EPA’s obligation to regulate areasources listed for regulation pursuant toClean Air Act section 112(c)(3).DATES: The final rule is effective onDecember 28, 2007.ADDRESSES: EPA has established adocket for this action under Docket IDNo. EPA–HQ–OAR–2005–0171. Alldocuments in the docket are listed inthe Federal Docket Management Systemindex at http://www.regulations.gov.Although listed in the index, someinformation is not publicly available,e.g., confidential business informationor other information whose disclosure isrestricted by statute. Certain othermaterial, such as copyrighted material,is not placed on the Internet and will bepublicly available only in hard copyform. Publicly available docketmaterials are available eitherelectronically throughwww.regulations.gov or in hard copy atthe EPA Docket Center in the EPAHeadquarters Library, Room Number3334 in the EPA West Building, locatedat 1301 Constitution Ave., NW.,Washington, DC. The EPA/DC PublicReading Room hours of operation are8:30 a.m. to 4:30 p.m. Eastern StandardTime (EST), Monday through Friday,excluding legal holidays. The telephonenumber for the Public Reading Room is(202) 566–1744. For the Air andRadiation Docket and InformationCenter, the telephone number is (202)566–1742, the fax number is (202) 566–9744, the Web site is http://www.epa.gov/oar/docket.html, and thee-mail address is a-and-r-Docket@epa.gov.FOR FURTHER INFORMATION CONTACT: Mr.David Markwordt, Office of AirPlanning and Standards, Sector Policiesand Programs Division, Coatings andChemicals Group (E143–01),Environmental Protection Agency,Research Triangle Park, NC 27711,telephone number: (919) 541–0837; faxnumber: (919) 541–0246; e-mail address:markwordt.david@epa.gov.SUPPLEMENTARY INFORMATION: Outline.The information presented in thispreamble is organized as follows:I. General InformationA. Does this action apply to me?B. Where can I get a copy of thisdocument?C. Judicial ReviewII. Background Information for Final AreaSource StandardIII. Summary of the Final Rule andSignificant Changes Since ProposalA. What is the affected source and thecompliance date?B. What is required by the managementpractice?C. What are the testing and initialcompliance requirements?D. What are the notification,recordkeeping, and reportingrequirements?IV. Exemption of Certain Area SourceCategories From Title V PermittingRequirementsV. Summary of Comments and ResponsesA. Proposed Alternative 1: ManagementPracticeB. Proposed Alternative 2: No ControlC. Add-on ControlsVI. Summary of Environmental, Energy, Cost,and Economic ImpactsVII. Statutory and Executive Order ReviewsA. Executive Order 12866: RegulatoryPlanning and ReviewB. Paperwork Reduction ActC. Regulatory Flexibility ActD. Unfunded Mandates Reform ActE. Executive Order 13132: FederalismF. Executive Order 13175: Consultationand Coordination with Indian TribalGovernmentsG. Executive Order 13045: Protection ofChildren From Environmental HealthRisks and Safety RisksH. Executive Order 13211: ActionsConcerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or UseI. National Technology Transfer andAdvancement ActJ. Executive Order 12898: Federal Actionsto Address Environmental Justice inMinority Populations and Low-IncomePopulationsK. Congressional Review ActI. General InformationA. Does this action apply to me?The regulated categories and entitiespotentially affected by these finalstandards include:CategoryNAICS 1 codeExample of potentiallyregulated entitiesGeneral Medical and Surgical Hospitals ............................................................................................. 622110 Hospital sterilizers.Specialty (Except Psychiatric and Substance Abuse) Hospitals ........................................................622310 Hospital sterilizers.1North American Industrial Classification System.pwalker on PROD1PC71 with RULESThis table is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beaffected by this action. To determinewhether your facility is regulated by thisaction, you should examine theapplicability criteria in 40 CFR 63.10382of subpart WWWWW (NationalEmissions Standards for HospitalEthylene Oxide Sterilizers). If you haveany questions regarding theapplicability of this action to aparticular entity, consult either the airpermit authority for the entity or yourEPA regional representative as listed in40 CFR 63.13 of subpart A (GeneralProvisions).B. Where can I get a copy of thisdocument?In addition to being available in thedocket, an electronic copy of this finalaction is also available on theWorldwide Web through theTechnology Transfer Network (TTN).Following signature, a copy of this finalVerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1action will be posted on the TTN’spolicy and guidance page for newlyproposed or promulgated rules at thefollowing address: http://www.epa.gov/ttn/oarpg/. The TTN providesinformation and technology exchange invarious areas of air pollution control.C. Judicial ReviewUnder section 307(b)(1) of the CleanAir Act (CAA), judicial review of thisfinal rule is available only by filing apetition for review in the United States

73612 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULESCourt of Appeals for the District ofColumbia Circuit by February 26, 2008.Under section 307(d)(7)(B) of the CAA,only an objection to this final rule thatwas raised with reasonable specificityduring the period for public commentcan be raised during judicial review.This section also provides a mechanismfor EPA to convene a proceeding forreconsideration, ‘‘[i]f the person raisingan objection can demonstrate to the EPAthat it was impracticable to raise suchobjection within [the period for publiccomment] or if the grounds for suchobjection arose after the period forpublic comment (but within the timespecified for judicial review) and if suchobjection is of central relevance to theoutcome of the rule.’’ Any personseeking to make such a demonstration tous should submit a Petition forReconsideration to the Office of theAdministrator, U.S. EPA, Room 3000,Ariel Rios Building, 1200 PennsylvaniaAve., NW., Washington, DC 20460, witha copy to both the person(s) listed in thepreceding FOR FURTHER INFORMATIONCONTACT section, and the AssociateGeneral Counsel for the Air andRadiation Law Office, Office of GeneralCounsel (Mail Code 2344A), U.S. EPA,1200 Pennsylvania Ave., NW.,Washington, DC 20460. Moreover,under section 307(b)(2) of the CAA, therequirements established by this finalrule may not be challenged separately inany civil or criminal proceedingsbrought by EPA to enforce theserequirements.II. Background Information for FinalArea Source StandardSections 112(c)(3) and 112(k)(3)(B) ofthe CAA instruct EPA to identify notless than 30 hazardous air pollutants(HAP) which, as a result of emissionsfrom area sources, 1 present the greatestthreat to public health in the largestnumber of urban areas, and to listsufficient area source categories toensure that sources representing 90percent of the 30 listed HAP (the ‘‘urbanHAP’’) are subject to regulation.Consistent with these provisions, in1999, in the Integrated Urban Air ToxicsStrategy (64 FR 38706, 64 FR 38715–716, July 19, 1999), EPA identified the30 urban HAP and listed the sourcecategories that account for 90 percent ofthe urban HAP emissions. 21 An area source is a stationary source of HAPemissions that is not a major source. A major sourceis a stationary source that emits or has the potentialto emit 10 tons per year (tpy) or more of any HAPor 25 tpy or more of any combination of HAP.2 Since its publication in the Integrated Urban AirToxics Strategy in 1999, the area source categorylist has undergone several amendments.Under CAA section 112(d)(5), theAdministrator may, in lieu of standardsrequiring maximum achievable controltechnology (MACT) under section112(d)(2), elect to promulgate standardsor requirements for area sources ‘‘whichprovide for the use of generallyavailable control technologies ormanagement practices by such sourcesto reduce emissions of hazardous airpollutants.’’ As explained in theproposed national emission standardsfor hazardous air pollutants (NESHAP),we are setting standards for the HospitalSterilizers Area Source categorypursuant to section 112(d)(5) of theCAA. See 71 FR 64907, November 6,2006.III. Summary of the Final Rule andSignificant Changes Since ProposalThis section summarizes the final ruleand identifies and discusses thesignificant changes since proposal. Forchanges that were made as a result ofpublic comments, we have provideddetailed explanations of the changesand the rationale in the responses tocomments in section V of this preamble.A. What is the affected source and thecompliance date?This final rule applies to any existingor new hospital ethylene oxidesterilization facility that is an areasource of HAP. The owner or operatorof an existing area source must complywith this area source NESHAP byDecember 29, 2008. The owner oroperator of a new area source mustcomply with this area source NESHAPby December 28, 2007 or upon initialstartup, whichever is later.B. What is required by the managementpractice?In our November 6, 2006 proposal, weproposed two alternative emissionstandards for this area source category.As Alternative 1, we proposed to requirethat the affected source, as definedabove, sterilize full loads of medicalitems having common aeration timesexcept during emergency circumstancesthat dictate the use of less than fullloads to protect human health. AsAlternative 2, we proposed a findingthat there are no generally availablecontrol technologies or managementpractices (GACT) within the meaning ofCAA section 112(d)(5) for the HospitalSterilizers Area Source category. Asexplained in more detail in section V ofthis preamble, based on the commentsand information we received during thepublic comment period, we concludethat the management practice describedin Alternative 1 reflects GACT for thisarea source category, and we, therefore,VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1adopt Alternative 1 as the standard forarea source hospital ethylene oxidesterilization facilities.Specifically, the final rule requiresthat a hospital ethylene oxidesterilization facility sterilize full loadsof items having a common aeration timeexcept where medical necessity dictatesthe use of less than a full load to protecthuman health. As explained in moredetail in section V.A.3 of this preamble,the determination that a medicalnecessity exists must be made by ahospital central services staff, 3 ahospital administrator, or a physicianon duty. This management practiceapplies to all affected sources. Asexplained in more detail in sectionV.A.2 of this preamble, sources maydemonstrate compliance with thisrequirement by operating theirsterilizers with an air pollution controldevice and providing the certificationrequired in this final rule.C. What are the testing and initialcompliance requirements?There are no performance testrequirements for the managementpractice standard. Affected sources arerequired to submit an InitialNotification of Compliance Status thatnotifies EPA that they operate asterilizer covered by the rule and certifythat they are operating their sterilizersin accordance with the requirement ofthe rule.In the preamble to the proposed rule,we acknowledged that some hospitalsoperate their sterilizers with add-oncontrols and that such controls achievereductions in ethylene oxide emissionsthat are at least equivalent to theethylene oxide reductions resultingfrom the management practice.Therefore, the final rule includes theuse of a control device as an alternativecompliance option for the managementpractice requirement. Specifically, asource may demonstrate compliance bycertifying that it is operating itssterilizer(s) with an air pollution controldevice. The source must certify that itis running the sterilizer(s) in accordancewith any applicable State and/or localregulations, or, if there are no suchregulations, with manufacturers’specifications.D. What are the notification,recordkeeping, and reportingrequirements?As mentioned above, affected sourcesmust submit an Initial Notification ofCompliance Status that includes the3 Hospital central services staffs are healthcareprofessionals, including managers and technicians,who are either directly involved in or responsiblefor sterile processing at a hospital.

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73613pwalker on PROD1PC71 with RULESrequired compliance certificationdescribed above. The final rule does notrequire ongoing reporting.Except for hospital ethylene oxidesterilization facilities that demonstratecompliance by using add-on controls,affected sources must maintain on siterecords of the date and time of eachsterilization operation. If less than a fullload is sterilized due to medicalnecessity, the operator must record thisas well. These sterilization records mustbe kept in a form suitable and readilyavailable for expeditious review. Theymust be kept for 5 years and at least themost recent 2 years on site.IV. Exemption of Certain Area SourceCategories From Title V PermittingRequirementsSection 502(a) of the CAA providesthat the Administrator may exempt anarea source category from title V if hedetermines that compliance with title Vrequirements is ‘‘impracticable,infeasible, or unnecessarilyburdensome’’ on an area sourcecategory. See CAA section 502(a). InDecember 2005, in a nationalrulemaking, EPA interpreted the term‘‘unnecessarily burdensome’’ in CAAsection 502 and developed a four-factorbalancing test for determining whethertitle V is unnecessarily burdensome fora particular area source category, suchthat an exemption from title V isappropriate. See 70 FR 75320, December19, 2005 (Exemption Rule).The four factors that EPA identified inthe Exemption Rule for determiningwhether title V is ‘‘unnecessarilyburdensome’’ on a particular area sourcecategory include: (1) whether title Vwould result in significantimprovements to the compliancerequirements, including monitoring,recordkeeping, and reporting, that areproposed for an area source category (70FR 75323); (2) whether title Vpermitting would impose significantburdens on the area source category andwhether the burdens would beaggravated by any difficulty the sourcesmay have in obtaining assistance frompermitting agencies (70 FR 75324); (3)whether the costs of title V permittingfor the area source category would bejustified, taking into consideration anypotential gains in compliance likely tooccur for such sources (70 FR 75325);and (4) whether there areimplementation and enforcementprograms in place that are sufficient toassure compliance with the NESHAP forthe area source category, without relyingon title V permits (70 FR 75326).In discussing the above factors in theExemption Rule, we explained that weconsidered on ‘‘a case-by-case basis theextent to which one or more of the fourfactors supported title V exemptions fora given source category, and then weassessed whether considered togetherthose factors demonstrated thatcompliance with title V requirementswould be ‘unnecessarily burdensome’on the category, consistent with section502(a) of the Act.’’ See 70 FR 75323.Thus, in the Exemption Rule, weexplained that not all of the four factorsmust weigh in favor of exemption forEPA to determine that title V isunnecessarily burdensome for aparticular area source category. Instead,the factors are to be considered incombination, and EPA determineswhether the factors, taken together,support an exemption from title V for aparticular source category.In the Exemption Rule, in addition todetermining whether compliance withtitle V requirements would beunnecessarily burdensome on thehospital sterilizer area source category,we considered, consistent with theguidance provided by the legislativehistory of CAA section 502(a), whetherexempting the Hospital Sterilizer AreaSource category would adversely affectpublic health, welfare, or theenvironment. See 70 FR 15254–15255,March 25, 2005.In the proposed rule, we evaluated thefour factors described above in relationto the Hospital Sterilizer Area Sourcecategory and explained our proposedconclusion that the factors collectivelydemonstrated that compliance with titleV requirements would be unnecessarilyburdensome for the source category.Among other things, we explained inthe preamble to the proposed rule, thattitle V permitting would not result insignificant improvements to thecompliance requirements for theHospital Sterilizer Area Source category.In the proposal, we further explainedthat title V permitting may impose asignificant burden on facilities withinthis source category, some of which aresmall businesses. We explained that, formany facilities, the cost of obtaining atitle V permit may far exceed the cost ofcomplying with the final rule withoutsignificant gains in compliance. Basedon the above analysis, we proposed thattitle V permitting would be‘‘unnecessarily burdensome’’ forhospital sterilizer area sources. We alsoproposed that the exemptions from titleV would not adversely affect publichealth, welfare, and the environment.In response to the proposed rule, wereceived two comments concerning theproposed title V exemption. However,as discussed in more detail in sectionV.A.7 of this preamble, neithercomment addressed the above-VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1mentioned factors that we considered inproposing the title V exemption.Accordingly, our assessment of thesefactors remains unchanged in light ofthese comments. We, therefore, finalizethe proposed exemption for the HospitalSterilizer Area Source category in thisrule. Hospital sterilizer area sources arenot required to obtain title V permitssolely for purposes of being the subjectof this final NESHAP; however, if theyare otherwise required to obtain title Vpermits, such requirements are notaffected by this exemption.V. Summary of Comments andResponsesThe hospital sterilizer area source rulewas proposed on November 6, 2006 (71FR 64907). The 60-day comment periodended on January 5, 2007, and wereceived a total of 10 comment letters onthe proposed NESHAP. Comments werereceived from one industry tradeassociation, a representative of oneaffected facility, representatives fromtwo affected Federal agencies, onesterilant manufacturer, three State andlocal air pollution control agencies, oneState agency association, and oneprivate citizen. This final rule reflectsour consideration of all of the commentsreceived on the proposed action. Thissection summarizes the significantcomments received on the proposedNESHAP and our response thereto. Asummary of all of the minor commentsand EPA’s response thereto arepresented here in this preamble and inthe Response to Comments Document(RTC Document), which is available inDocket No. EPA–HQ–OAR–2005–0171.A. Proposed Alternative 1: ManagementPractice1. Management Practice ApproachComment: Two commenterssupported promulgation of themanagement practice approach, i.e.,Regulatory Alternative 1. One of thecommenters noted that EPA recognizesthat, by minimizing ethylene oxide usewith the management practice, hospitalethylene oxide sterilization facilitiesalso minimize ethylene oxide emissions.Both commenters expressed that theproposed management practicealternative ensures that hospitalssterilize the most number of medicaldevices per pounds of ethylene oxideemitted, and it is consistent withhospital practices.Two commenters stated that themanagement practice is common sense.One commenter argued that EPA’sproposed GACT were neither acceptablenor consistent with legal requirements.Another commenter stated that EPA’s

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. Hospitals 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, Ethylene

73616 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULESOxide Sterilization in Health CareFacilities: Safety and Effectiveness,ANSI/AAMI ST 41:1999. According tothe commenter, the sterilizer recordsunder this standard include thefollowing: Load or lot number; itemdescription and quantity; thedepartment; the name of the sterilizeroperator; aeration time and temperature;results of the biological monitoring(which is processed with each load toensure that sterilization has occurred);chemical indicator results; and reportsof nonresponsive chemical indicators.Two commenters stated that hospitalskeep a record of each load they run fortraceability. Two commenters statedthat hospitals could probably add a fewmore items of information to theirrecords to comply with EPA’srequirements. These commentersrecommended that EPA’s recordkeepingrequirements be consistent withhospitals’ current practice inmaintaining records of sterilized loads.Two commenters indicated that someState programs require keepingsterilization records, and onecommenter stated that some States haverequired such recordkeeping for manyyears. The commenters indicated thatsome hospitals keep such recordsthrough computerized recordkeepingsystems while others use handwrittenrecords. The commenters believed thatthese requirements are not likely to beoverly burdensome or costly to thefacilities.Response: In light of the commentsindicating that hospitals are alreadykeeping records of each sterilizationcycle and that such recordkeepingprovisions are not overly costly orburdensome, we are requiring affectedfacilities to keep sterilization records inthe final rule. Specifically, the final rulerequires that a facility record the dateand time of each sterilization cycle,whether each sterilization cyclecontains a full load of items, and, foreach partial load, state that it wasmedically necessary. Based oninformation provided during thecomment period, we believe that thisrecordkeeping requirement is consistentwith hospitals’ current practice. We alsobelieve the time required to keep theserecords would be offset by the timesaved by the reduced cycles run.7. Title V PermittingComment: One commenter favoredtitle V permitting. The commenterstated that, by requiring title V permits,title V funds could be used to assurecompliance. The commenter noted that,according to an EPA Regional office,title V funds cannot be used for non-titleV programs. The commenter stated thatif, from a national perspective, EPAprefers to exempt area sources such asthese from title V permitting, EPAshould explain the level of effort theyexpect from State and local agencies,and develop a funding mechanism forthat effort. The commenter further notedthat, in this case, the commenter’s Statealready has operating permits foraffected facilities and that there wouldbe little cost involved in updating thesepermits to reflect the Federal ruleduring the normal permit renewalprocess.Response: As discussed in thepreamble to the proposed rule, EPAconsidered four factors in determiningwhether title V is ‘‘unnecessarilyburdensome’’ for a particular areasource category. Based on itsconsideration of these factors, EPAconcluded that the requirements of titleV would be unnecessarily burdensomefor area source hospital ethylene oxidesterilization facilities. Among otherthings, EPA concluded that title Vpermitting would not result insignificant improvements to thecompliance requirements for thehospital ethylene oxide sterilizationarea source category and that title Vpermitting would likely impose asignificant burden on facilities withinthe source category, some of which aresmall businesses. The Agency alsofound that, for many facilities, the costof obtaining a title V permit may farexceed the cost of complying with thefinal rule without significant gains incompliance. EPA further determinedthat the proposed exemptions from titleV would not adversely affect publichealth, welfare, and the environment.Although the commenter advocatestitle V permitting, the commenter failedto address EPA’s application of the fourfactors described above, and itsconclusion that the proposedexemptions would not adversely affectpublic health, welfare, and theenvironment. Indeed, none of thecommenters disagreed with any ofEPA’s proposed findings describedabove and in the proposed rule thatserved as the basis for the proposed titleV exemption.Instead of challenging EPA’sapplication of the four factors relevantto determining whether title Vrequirements would be unnecessarilyburdensome on a particular area sourcecategory, the commenter focuses on thefact that, in its State, area sourcehospital sterilizers have State operatingpermits and that adding therequirements of this rule to thosepermits would involve little costs. Thefact that title V permitting may not beburdensome or costly in one State doesVerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1not reflect the burden or costsassociated with title V permittingnationwide. Once again, the commenterhas not identified any flaws in EPA’sapplication of the four factor testdescribed above, which involve anassessment of the costs of title Vreporting for the entire source category.Therefore, for the reasons discussedabove and in the proposed rule, we areexempting area source hospital ethyleneoxide sterilization facilities from therequirements of title V in this final rule.The commenter apparently favoredtitle V permitting based on its belief that‘‘by requiring title V permits, EPAwould allow title V funds to be used toassure compliance.’’ The commenterrequested that EPA explain the level ofState and local efforts that may beinvolved in implementing and enforcingthe requirements of the final rule anddevelop a funding mechanism for thateffort. We expect such effort to beminimal. We believe that themanagement practice and the associatedrecordkeeping requirements in this finalrule are straightforward and can,therefore, be easily implemented andenforced. Further, according to thecomments received, the managementpractice requirement is consistent withhospital practices and hospitals arealready keeping records of sterilizationcycles. In light of the above, we do notanticipate that State and local agencieswould need to spend a significant levelof effort to implement and enforce thisrule. EPA, however, remains committedto working with State and local agenciesto implement this rule. State and localagencies that receive grants forcontinuing air programs under CAAsection 105 should work with theirproject officers to determine whatresources are necessary to implementand enforce this area source standard.EPA will continue to provide theresources appropriated for CAA section105 grants consistent with the statuteand the allotment formula developedpursuant to the statute.Comment: One commenter agreedwith EPA’s proposal that title V permitsare not necessary for area sources. Thecommenter noted that some hospitals,however, already have or are covered bytitle V permits, and that any rulemakinghas the potential to impose additionalpermit modification costs. Thecommenter asserted that EPA shouldminimize title V permitting cost impactsby adding a provision in this rule statingthat an existing title V permit does nothave to be reopened or revised toaddress the requirements of this ruleuntil the next time the permit isrenewed, reopened, or revised foranother reason. The commenter

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73617pwalker on PROD1PC71 with RULESalternatively proposed that EPAconsider an exemption similar to thatwhich was included in 40 CFR63.7881(c)(3) of the recently finalizedamendments to the Site RemediationNESHAP.Response: The commenter requestedthat EPA prescribe in this rule the timefor reopening and revising existing titleV permits for area source hospitalsterilizers. CAA section 502(a)authorizes EPA to exempt an areasource category from title V permittingif the Administrator finds thatcompliance with title V isimpracticable, infeasible, orunnecessarily burdensome on suchcategory; however, to the extent thatsome sources within this area sourcecategory are already otherwise requiredto obtain title V permits, CAA section502(a) does not authorize EPA to affectin any way these sources’ existingobligations under title V, includingwhen the permits must be renewed. Asdiscussed above, pursuant to CAAsection 502(a), EPA has determined thatthe requirements of title V would beunnecessarily burdensome for areasource hospital ethylene oxidesterilization facilities. Accordingly, thisfinal rule exempts area sourcesterilization facilities from theobligation to obtain title V permits forpurposes of being subject to therequirements of this rule. Thecommenter, however, is requesting thatEPA prescribe in this rule the time forreopening and revising existing title Vpermits for area source hospitalsterilizers. The commenter’s request isunrelated to and beyond the scope ofEPA’s authority to issue this area sourcerule pursuant to CAA sections 112(c)(3)and 112(d)(5). The request is alsobeyond the scope of EPA’s authorityunder CAA section 502(a) to exemptarea sources from title V permitting. We,therefore, reject the commenter’s requestto include its recommended language inthis final rule.B. Proposed Alternative 2: No ControlComment: One commenterrecommended that EPA selectRegulatory Alternative 2 (the noadditional control alternative). Thecommenter stated that hospitals havestrong economic incentives to operatesterilizers with a full load because doingso reduces both material and labor costs.According to the commenter, becauseeconomics already drive hospitalethylene oxide sterilization facilities toimplement the management practice,Alternative 1 is unlikely to result insignificant emission reduction. Thecommenter states that it has encouragedits facilities to switch to alternativesterilization methods and, therefore,there are not many ethylene oxidesterilizers at its facility.Response: As previously mentioned,we included two regulatory alternativesin the proposed rule. As Alternative 1,we proposed to require that hospitalssterilize full loads of medical itemshaving common aeration times exceptduring emergency circumstances thatdictate the use of less than full loads toprotect human health. However, at thetime of the proposal, we had limitedinformation to conclude that theproposed management practice inAlternative 1 reduced ethylene oxideemissions or was cost-effective.Therefore, we included an alternativeproposal (Alternative 2) that there areno GACT within the meaning of CAAsection 112(d)(5) for the HospitalSterilizers Area Source category. Wealso solicited comments on the costsand emission reduction estimates for themanagement practice.As explained in more detail in sectionV.A.1 of this preamble, we have sincereceived comments indicating that themanagement practice minimizesethylene oxide emissions by minimizingethylene oxide use and that the practiceis cost-effective. We, therefore, concludethat the management practicerequirement we proposed as Alternative1 reflects a generally availablemanagement practice within themeaning of CAA section 112(d)(5) forthis area source category.The commenter apparently agreedthat the management practice is costeffective.It stated that hospitals haveeconomic incentives to run thesterilizers full because it reduces bothlabor and material costs. Thecommenter, nevertheless, recommendedAlternative 2, claiming that Alternative1 may not achieve significant reductionsince it is already being implemented.However, the CAA does not require aGACT standard to achieve any specificlevel of emission reduction.As explained above, we havedetermined that the managementpractice that we proposed as Alternative1 represents GACT for this area sourcecategory. The commenter offered noinformation suggesting otherwise.Having determined that our proposedAlternative 1 represents GACT, we canno longer conclude that there are noGACT within the meaning of CAAsection 112(d)(5). We, therefore, rejectthe commenter’s recommendation thatwe adopt the no control option(Alternative 2) in this final rule.VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1C. Add-on Controls1. Cost ConsiderationsComment: Four commentersrecommended that EPA require add-oncontrols for the area source hospitalethylene oxide sterilizers. Twocommenters noted that, in the preambleto the proposed rule, EPA stated that thetwo predominant types of controldevices (i.e., acid-water scrubbers andcatalytic oxidation units) reduceemissions by approximately 99 percent.One of these two commenters also notedthat, according to the NationalToxicology Program, researchers havedemonstrated that the application ofthese control technologies to hospitalsterilizers effectively reduce ethyleneoxide concentrations. This commenter,therefore, concluded that proven controltechnology is readily available tocontrol ethylene oxide emissions fromhospital sterilizers and that applicationof this technology is practicable,feasible, prudent, and not unnecessarilyburdensome. Two commenters drew thesame conclusion, noting that the controltechnologies have been required bysome State programs for many years.One commenter similarly stated that ifmore than half of the sources alreadyhave add-on controls, it suggests thatthese controls are practical and feasible.One commenter expressed that, withnearly half of the hospitals using addoncontrols, it is hard to understandEPA’s rationale in the proposed rulethat add-on controls are too costly. Onecommenter suggested that, if cost is tobe considered, EPA should consider afull array of alternatives, including thecost of alternatives to sterilization andalternative means of sterilization, andcompare them to the cost of controllingethylene oxide sterilization. Thecommenter stated that the proposed rulepresumes ethylene oxide sterilizationmust be preserved. The commenternoted that in the Hospital, Medical,Infectious Waste Incinerator (HMIWI)standard, however, EPA recognized thatthere were alternatives to incineration ofthe wastes and, therefore, requiredemission controls that were notnecessarily cost-effective. Thecommenter recommended that the sameapproach should be applied here.One commenter stated that installingcontrol would be an unnecessary cost tohospitals providing no benefits. Thecommenter observed that hospitalethylene oxide sterilization has declineddue to Occupational Safety and HealthAdministration regulations, newsterilization methods, and new designsand materials used in medical devices.The commenter, however, emphasizedthat ethylene oxide sterilization is a

73618 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULESnecessity in hospitals. The commenterexplained that the medical devicesprocessed by ethylene oxide areexpensive and that hospitals can onlyafford minimal amounts on hand. Thecommenter further explained that someof the medical devices are old andcannot be replaced. The commenternoted that these devices are typicallyutilized in surgical areas. Thecommenter stated that EPA’s rationalemakes clear that existing ethylene oxideemission control technology will notprovide the type of cost-benefit neededto justify new hospital investment in thecontrol devices. The commenter notedthat the cost of add-on control wouldinclude not just the cost of the device,but also the cost of installation, facilitymodification, annual testing of controldevices, and utility and maintenance.Response: CAA section 112(d)(5)provides that, with respect to areasource categories listed pursuant toCAA section 112(c), the Administratormay, in lieu of MACT, promulgatestandards or requirements whichprovide for the use of GACT. Asexplained in the preamble to theproposed rule, EPA is issuing thestandards for the hospital sterilizers areasource category under CAA section112(d)(5).In determining what constitutesGACT for a particular area sourcecategory, EPA evaluates the controltechnologies and management practicesthat reduce HAP emissions and aregenerally available for the area sourcecategory. The legislative historysupporting CAA section 112(d)(5)provides that EPA may consider costs indetermining what constitutes GACT forthe area source category. 5In considering costs, the commenterswho recommended add-on controlfocused mainly on the actual costs tohospitals and asserted that such controlis likely not too costly if many hospitalsare using it under existing State or localrequirements. As we stated in thepreamble to the proposed rule, EPArecognizes that over half of the hospitalsuse add-on controls. However, theactual cost to individual hospitals is butone cost factor that we considered inthis rulemaking. We also noted that thetotal annualized cost for add-on5 Additional information on the definition of‘‘generally available control technologies ormanagement practices’’ (GACT) is found in theSenate report on the 1990 amendments to the CAA(S. Rep. No. 101–228, 101st Cong. 1st session. 171–172). That report states that GACT is to encompass:* * * methods, practices and techniques which arecommercially available and appropriate forapplication by the sources in the categoryconsidering economic impacts and the technicalcapabilities of the firms to operate and maintain theemissions control systems.controls, which we estimated to be $8.5million, exceeds the total annualizedcost for the management practice, whichwe estimated to range from $32,000 to$61,000, by more than 100 fold. Inaddition, we considered the costeffectivenessof the add-on controls.See, e.g., Husquavarna AB v. EPA, 439U.S. App. DC 118, 254 F.3d 195, 201(DC Cir. 2001) (finding EPA’s decisionto consider costs on a per ton ofemissions removed basis reasonablebecause CAA section 213 did notmandate a specific method of costanalysis). EPA’s cost analysis for theadd-on controls showed poor costeffectiveness.Specifically, EPA’s costeffectivenessestimate for add-oncontrols was $200,000 per ton ofethylene oxide reduced. This costeffectivenessexcludes monitoring,recordkeeping, and reporting costs.We also considered alternatives toethylene oxide sterilization, as onecommenter suggested. We learned fromseveral commenters that, althoughethylene oxide sterilization in hospitalshas declined, it remains a necessity forcertain medical devices that cannot beeasily replaced or sterilized by othermeans. We agree with these commentersthat, in light of the declined level ofethylene oxide sterilization and the lackof alternatives for sterilizing certainunique and expensive medical devices,the benefit of requiring add-on controlis outweighed by the various costsassociated with such control. Based onthe foregoing, we determined that addoncontrols do not represent GACT forthis area source category.One commenter argued that EPArequired add-on control in the HMIWIstandard that were not necessarily costeffectiveand that EPA should take thesame approach in this final rule. 6 TheHMIWI standard, however, waspromulgated pursuant to section 129 ofthe CAA, which requires that EPAestablish standards that reflect theMACT. Consistent with therequirements of CAA section 129, EPAissued the original HMIWI standardsbased on MACT. CAA section 129(a)(2)does not allow EPA to consider costs insetting the floor for control. By contrast,EPA is issuing this final rule pursuantto CAA section 112(d)(5), which allowsEPA to consider costs, including costeffectiveness,in establishing GACT.Thus, the HMIWI rule is not relevant,6 40 CFR part 60, subpart Ce—EmissionGuidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators (constructedon or before June 20, 1996).40 CFR part 60, subpart Ec—Standards ofPerformance for Hospital/Medical/Infectious WasteIncinerators for Which Construction is CommencedAfter June 20, 1996.VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1because in that rule, EPA, by statute,could not consider costs.2. Best Available Control Technology(BACT) or MACTComment: One commenter stated that,because ethylene oxide is a knownhuman carcinogen, its emissions shouldbe controlled using the BACT. Thecommenter stated alternatively that, dueto the widespread use of control onhospital sterilizers, the MACT floorlevel of control would be add-oncontrols under CAA section 112(d)(2).The commenter stated that, based on theexperience in its State, the MACT floorand associated recordkeeping arefeasible and prudent and, therefore,none of EPA’s proposals are inaccordance with legal requirements. Thecommenter claimed that the proposedNESHAP must be revised to representMACT floor of add-on emission controland recordkeeping as required by law.Response: CAA section 112(c)(2)requires that EPA establish emissionstandards under CAA section 112(d) forthe categories listed under CAA section112(c), including area source categorieslisted pursuant to CAA section112(c)(3). As mentioned above, EPAmay issue standards for listed areasource categories based on MACT (CAAsection 112(d)(2)) or GACT (CAAsection 112(d)(5)). CAA Section 112(d)does not contain a standard based onBACT. Therefore, EPA rejects thecommenter’s request to require the useof BACT because such standard is notauthorized by the CAA.The commenter also arguedalternatively that neither of EPA’sproposed alternatives was in accordancewith legal requirements and that EPAmust issue a MACT standard as requiredby law. The commenter, however, didnot identify any legal requirement thatallegedly is not satisfied by EPA’sproposed alternatives or requires EPA toissue a MACT standard for the HospitalSterilizer Area Source category. On thecontrary, the commenter noted that‘‘EPA is ’exercising discretion’ inpromulgating standards or requirementsunder section 112(d)(5) of the CAA.’’Although the commenter acknowledgedthat EPA has discretion under CAAsection 112(d)(5) to issue a GACTstandard in lieu of a MACT standard forlisted area source categories, it claimedthat, based on its State’s experiencewith regulating and controlling ethyleneoxide emissions from hospitalsterilizers, the MACT floor andassociated recordkeeping are feasibleand prudent. The commenter arguedthat, therefore, neither of EPA’sproposals is acceptable in accordancewith legal requirements and that EPA

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73619pwalker on PROD1PC71 with RULESmust issue a MACT standard as requiredby law.The commenter’s argument seems toimply that EPA must first find that aMACT standard is infeasible,imprudent, or otherwise inappropriatebefore the Agency can legally issue aGACT standard for an area sourcecategory pursuant to section 112(d)(5) ofthe CAA. However, there is no suchrequirement under the CAA. In fact, theCAA does not contain any conditionprecedent for issuing a GACT standardunder CAA section 112(d)(5). CAAsection 112(d)(5), which is entitled‘‘Alternative standard for area sources,’’provides:With respect only to categories andsubcategories of area sources listed pursuantto subsection (c) of this section, theAdministrator may, in lieu of the authoritiesprovided in paragraph (2) and subsection (f)of this section, elect to promulgate standardsor requirements applicable to sources in suchcategories or subcategories which provide forthe use of generally available controltechnologies or management practices bysuch sources to reduce emissions ofhazardous air pollutants. (Emphasis added).There are two critical aspects to CAAsection 112(d)(5). First, CAA section112(d)(5) applies only to thosecategories and subcategories of areasources listed pursuant to CAA section112(c). The commenter does not disputethat EPA listed the Hospital SterilizerArea Source category pursuant to CAAsection 112(c)(3). Second, CAA section112(d)(5) provides that, for area sourceslisted pursuant to CAA section 112(c),EPA ‘‘may, in lieu of ’’ the authoritiesprovided in CAA section 112(d)(2) and112(f), elect to promulgate standardsthat provide for the use of generallyavailable control technologies ormanagement practices (GACT). Section112(d)(2) provides that emissionstandards established under thatprovision ‘‘require the maximum degreeof reduction in emissions’’ of HAP (alsoknown as MACT). 7 Webster’s dictionarydefines the phrase ‘‘in lieu of’’ to mean‘‘in the place of’’ or ‘‘instead of.’’ SeeWebster’s II New Riverside University(1994). Thus, CAA section 112(d)(5)authorizes EPA to promulgate standardsthat provide for the use of GACT insteadof issuing MACT standards. The statutedoes not set any condition precedent forissuing standards under CAA section112(d)(5) other than that the area source7 CAA section 112(d)(5) also references CAAsection 112(f). See CAA section 112(f)(5) (entitled‘‘Area Sources’’ and providing that EPA is notrequired to conduct a review or promulgatestandards under CAA section 112(f) for any areasource category or subcategory listed pursuant toCAA section 112(c)(3) and for which an emissionstandard is issued pursuant to CAA section112(d)(5)).category or subcategory at issue must beone that EPA listed pursuant to CAAsection 112(c), which is the case here.Had Congress intended that EPA firstconduct a MACT analysis for each areasource category and only if cost or someother reason made applying the MACTstandard inappropriate for the categorywould EPA be able to issue a standardunder CAA section 112(d)(5), Congresswould have stated so expressly in CAAsection 112(d)(5). Congress did notrequire EPA to conduct any MACTanalysis, floor analysis, or beyond-theflooranalysis before the Agency couldissue a CAA section 112(d)(5) standard.Rather, Congress authorized EPA toissue GACT standards for area sourcecategories listed under CAA section112(c)(3), and that is precisely whatEPA has done in this rulemaking.Although EPA has no obligation tojustify why it is issuing a GACTstandard for an area source category asopposed to a MACT standard, we did soin the proposed rule. See 71 FR 64910,November 6, 2006. As explained in theproposed rule, we determined that theMACT floor level of control would beadd-on controls if we were to developthis area source rule based on CAAsection 112(d)(2). As explained in moredetail in section V.C.1 of this preamble,we took costs into consideration anddetermined that the benefit of requiringadd-on controls is outweighed by thecosts associated with such control. Webelieve the consideration of costs isespecially important for the wellcontrolledarea sources at issue in thisfinal action because, given current wellcontrolledlevels, a MACT floordetermination, where costs cannot beconsidered, could result in onlymarginal reductions in emission at veryhigh costs.3. Consideration of Health Impacts orRisksComment: According to onecommenter, EPA’s decision not torequire add-on control appears to bebased on cost-effectiveness withoutmuch regard for heath impact or risk.The commenter argued that anappropriate analysis would consider thehealth impacts where people areexposed. Four commenters identifiedhealth risks from ethylene oxideexposure as a basis for requiring add-oncontrol. The commenters noted thatethylene oxide is a carcinogen anddescribed in detail health effects fromethylene oxide exposure. In addition,one commenter stated that, since thesesterilization units are located inhospitals which are densely populatedwith staff and patients, extra careshould be taken to assure their healthVerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1and safety. One commenter expressedconcern that people living, working, andvisiting the vicinity of the uncontrolledsources (i.e., those that do not have addoncontrols) are not afforded the samelevel of protection as those nearcontrolled sterilizers.Two commenters stated that hospitalethylene oxide emissions are minimaland declining and that the potentialrisks of ethylene oxide emissions, basedon the EPA analysis, are also minimal.Accordingly, both commenters statedthat there is no benefit for installingethylene oxide emission controlequipment, and one commenter statedthat any benefits would be insignificantand far outweighed by the real costsassociated with the control.Response: As previously explained,pursuant to sections 112(c)(3) and112(k)(3)(B) of the CAA, EPA identifiedethylene oxide as one of 30 HAP thatpresent the greatest threat to publichealth in the largest number of urbanareas and listed Hospital SterilizersArea Source as a category needed toensure that sources representing 90percent of area source ethylene oxideemissions are subject to regulation.In the 1990 CAA Amendments,Congress established a two-phaseapproach for setting HAP emissionstandards. Sierra Club v. EPA, 353 F.3d976, 980 (D.C. Cir. 2004). The first phaseis the initial standard setting phase,which is the phase at issue in thisrulemaking. 8 In this phase, thestandards are technology-based, and thisis true regardless of whether we issueMACT standards under CAA section112(d)(2) and (d)(3), or GACT standardsunder CAA section 112(d)(5). 9 SeeSenate Report at 148 (1989); Sierra Clubv. EPA, 353 F.3d at 980.In this final rule, EPA is establishingemissions standards for this area sourcecategory under CAA section 112(d)(5),which authorizes EPA to set emissionsstandards based on GACT for a listedarea source category. The legislativehistory describes GACT as ‘‘methods,practices, and techniques which are8 The second phase of standard setting involvesa risk-based analysis. Specifically, CAA section112(f)(2) requires EPA to determine—8 years afterissuance of the initial MACT standard—whetherresidual risks remain that warrant more stringentstandards than achieved through MACT. CAASection 112(f)(5) provides that the Agency shall notbe required to conduct a residual risk for areasources for which EPA has issued a GACT standard.9 CAA Section 112(d)(4) does provide, however,that with respect to pollutants for which the EPAAdministrator has established a health threshold,EPA can consider such threshold in settingstandards under CAA section 112(d). Ethyleneoxide is a carcinogen and is, thus, not a pollutantfor which the Administrator has established ahealth threshold, and, therefore, CAA section112(d)(4) is not relevant to this category.

73620 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULEScommercially available and appropriatefor application by sources in thecategory considering economic impactsand the technical capabilities of thefirms to operate and maintain theemissions control systems.’’ S. Rep. No.101–228, at 171 (1989) (Senate Report).Consistent with the statute and thelegislative history, in determiningGACT, we evaluated the controltechnologies and management practicesthat reduce HAP emissions from theethylene oxide Hospital Sterilizer AreaSource category, and we assessed thecosts of implementing such approaches.We did not consider health impacts orrisks in establishing the emissionstandards for the Hospital SterilizerArea Source category, as thecommenters recommended, nor were werequired by statute to do so. However,we note that health risk did play a rolein this process in that the determinationof which pollutants to regulate and fromwhich categories was governed by thestatutory requirement to regulatesources accounting for 90 percent ormore of the 30 HAP that present thegreatest health threat in urban areas.4. Potential BackslidingComment: One commenter noted thatmany hospital ethylene oxide sterilizersare controlled (i.e., with add-oncontrols) as the result of State and localprograms. The commenter stated that inthe preamble to the proposed rule, EPArecognizes the contributions of the Stateand local programs and is apparentlyrelying upon them to ensure adequatecontrol of hospital sterilizers. Thecommenter stated that EPA’s proposal torely on these programs, in lieu ofFederal requirements, is unwise andinappropriate. The commenter statedthat the existence of State and localregulations does not relieve the agencyof its duty to set emissions controlrequirements under CAA section 112.The commenter further noted that manyState and local agencies are not able tobe more stringent than Federalrequirement and that it is conceivablethat some agencies could be required tochange their regulations to be consistentwith those of the Federal government,resulting in relaxing of existing non-Federal rules. The commenter alsoclaims that State and local regulationscan change in the future for otherreasons. The commenter stated that, inthe absence of Federal requirements,there would be nothing to preventbacksliding by the sources if a State orlocal rule is realized or eliminated.Another commenter stated that forsources in its State, EPA’s issuance ofthis rule means that existing sourceswould continue to be subject to theState air toxics rule that requires 99percent control, but new sources wouldonly be subject to EPA’s requirement.The commenter stated that this amountsto backsliding on emission controlrequirements and an increase inemissions.Response: EPA has not shed itsresponsibility to set emission standardsunder CAA section 112 because ofexisting State and local regulations. Onthe contrary, EPA is issuing this finalrule today to regulate ethylene oxideemissions from hospital sterilizers. Asdescribed above, pursuant to CAAsection 112(d)(5), EPA has establishedin this final rule a management practicerequirement that represents GACT forthis area source category. EPA did notreject the add-on control option in thisrulemaking because it was relying onexisting State and local programs torequire add-on controls, as onecommenter contended. Rather, aspreviously explained in section V.C.1 ofthis preamble, EPA concludes that addoncontrols do not represent GACT forthis area source category.Two commenters expressed concernthat certain States may require that theirexisting regulations be relaxed as not tobe more stringent than EPA’s standards.However, CAA section 112(l) onlyprohibits States from setting standardsthat are less stringent than EPA’sstandards; the CAA does not affect Stateand local emission standards that aremore stringent than the requirements ofthis final rule. The issue of potentialbacksliding that the commenters raisedis based on State law, which EPA has noauthority to change. We, however,encourage States to revisit their Statelaws to address this concern.5. Emissions From AerationComment: One commenter noted thatsome sterilizers only operate theircatalytic control devices during theinitial purge of ethylene oxide(following sterilization) and not duringthe entire aeration cycle. Thecommenter stated that the controldevice should be used for all discharges,not just the initial purge.Response: The commenter appears tobe arguing that a control device shouldbe used to control both sterilization andaeration ethylene oxide emissionsinstead of just sterilization emissions.The final rule does not, however,require the use of a control device. EPAhas determined that the managementpractice in the final rule representsGACT and requires that hospitals runsterilizers in full loads except duringmedically necessary circumstances.This requirement will reduce bothsterilization and aeration ethylene oxideVerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1emissions by reducing the amount ofethylene oxide usage.Although the final rule does notrequire the use of a control device, itallows the use of a control device as analternative compliance option for themanagement practice requirementbecause the use of a control deviceachieves reduction in ethylene oxideemissions that are at least equivalent tothe ethylene oxide reduction resultingfrom the management practice. This istrue even if the control device is usedto control ethylene oxide emissionsfrom sterilization only. Therefore,controlling aeration emissions with acontrol device is not necessary underthe alternative compliance option.VI. Summary of Environmental, Energy,Cost, and Economic ImpactsWe estimate that in 2002 there were,at most, 1,900 hospital area sources thatconduct ethylene oxide sterilization, ofwhich approximately 630 do notpresently have add-on controls. Thefinal management practice wasestimated at proposal to reduce the 44tpy emitted from ethylene oxidesterilizers by 2 to 9 tpy. We did notreceive any comments that would allowus to improve this estimate. Severalcommenters, however, stated that theyare already employing the managementpractice. With the management practice,we believe there is minimal effect oneither air quality or non-air qualityenvironmental impacts and there arenegligible energy or economic impacts.Annualized costs to comply with thefinal standards are estimated to rangefrom $32,000 to $61,000 per year.VII. Statutory and Executive OrderReviewsA. Executive Order 12866: RegulatoryPlanning and ReviewUnder Executive Order 12866 (58 FR51735, October 4, 1993), this action is a‘‘significant regulatory action’’ becauseit may raise novel legal or policy issues.Accordingly, EPA submitted this actionto the Office of Management and Budget(OMB) for review under ExecutiveOrder 12866, and any changes made inresponse to OMB recommendationshave been documented in the docket forthis action.B. Paperwork Reduction ActThe information requirements in thisrule have been submitted for approval toOMB under the Paperwork ReductionAct, 44 U.S.C. 3501, et seq. Theinformation collection requirements arenot enforceable until OMB approvesthem.The recordkeeping and reportingrequirements in the final rule are based

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73621pwalker on PROD1PC71 with RULESon the information collectionrequirements in the 40 CFR part 63General Provisions (subpart A), some ofwhich are incorporated into the finalNESHAP. The ICR document includesthe burden estimates for all applicableGeneral Provisions. The recordkeepingand reporting requirements in theGeneral Provisions are mandatorypursuant to section 114 of the CAA (42U.S.C. 7414). All information submittedto EPA pursuant to the informationcollection requirements for which aclaim of confidentiality is made issafeguarded according to CAA section114(c) and the Agency’s implementingregulations at 40 CFR part 2, subpart B.The final NESHAP for area sourcesrequires a one-time initial notificationby hospital ethylene oxide sterilizationfacilities certifying that the facility is incompliance with rule requirements andrequires recordkeeping for eachsterilization cycle for sterilizers notequipped with an air pollution controldevice.The annual burden for theinformation collection averaged over thefirst 3 years of this ICR is estimated tototal 3,576 labor hours per year at a costof $245,000 for the 1,900 existinghospital sterilizer area sources. Smallannualized capital/startup costs andsmall operation and maintenance costsare associated with the requirements.No costs or burden hours are estimatedfor new area sources because no newsources are estimated during the next 3years. Burden means the total time,effort, or financial resources expendedby persons to generate, maintain, retain,or disclose or provide information to orfor a Federal agency. This includes thetime needed to review instructions;develop, acquire, install, and utilizetechnology and systems for the purposesof collecting, validating, and verifyinginformation, processing andmaintaining information, and disclosingand providing information; adjust theexisting ways to comply with anypreviously applicable instructions andrequirements; train personnel to be ableto respond to a collection ofinformation; search data sources;complete and review the collection ofinformation; and transmit or otherwisedisclose the information.An agency may not conduct orsponsor, and a person is not required torespond to a collection of informationunless it displays a currently valid OMBcontrol number. The OMB controlnumbers for EPA’s regulations in 40CFR are listed in 40 CFR part 9. Whenthis ICR is approved by OMB, theAgency will publish a technicalamendment to 40 CFR part 9 in theFederal Register to display the OMBcontrol number for the approvedinformation collection requirementscontained in this final rule.C. Regulatory Flexibility ActThe Regulatory Flexibility Act (RFA)generally requires an agency to preparea regulatory flexibility analysis of anyrule subject to notice and commentrulemaking requirements under theAdministrative Procedure Act or anyother statute unless the agency certifiesthat the rule would not have asignificant economic impact on asubstantial number of small entities.Small entities include small businesses,small organizations, and smallgovernmental jurisdictions.For the purposes of assessing theimpacts of the area source NESHAP onsmall entities, small entity is defined as:(1) A small business that is a hospital asdefined by NAICS codes 622110 and622310 whose parent company has lessthan $31.5 million in gross revenue(based on Small BusinessAdministration (SBA) size standards);(2) a small governmental jurisdictionthat is a government of a city, county,town, school district, or special districtwith a population of less than 50,000;and (3) a small organization that is anynot-for-profit enterprise which isindependently owned and operated andis not dominant in its field.After considering the economicimpacts of this final rule on smallentities, I certify that this action will nothave a significant economic impact ona substantial number of small entities.The final rule requires the use of amanagement practice to minimize theoperation of the ethylene oxidesterilization unit and will, therefore,have minimal nationwide costs, i.e.,range from $32,000 to $61,000 per year.We have determined that less than 3percent of the hospitals are smallbusinesses as defined by the SBA. Wehave also determined that none of thesesmall businesses are significantlyimpacted by this proposal for none ofthem will incur annualized compliancecosts of 0.1 percent of sales or greater.Although this final rule will not havea significant economic impact on asubstantial number of small entities,EPA nonetheless has tried to reduce theimpact of this rule on small entities. Thefinal rule is designed to harmonize withexisting State or local requirements.D. Unfunded Mandates Reform ActTitle II of the Unfunded MandatesReform Act of 1995 (UMRA), PublicLaw 104–4, establishes requirements forFederal agencies to assess the effects oftheir regulatory actions on State, local,and tribal governments and the privateVerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1sector. Under section 202 of the UMRA,EPA generally must prepare a writtenstatement, including a cost-benefitanalysis, for proposed and final ruleswith ‘‘Federal mandates’’ that mayresult in expenditures to State, local,and tribal governments, in the aggregate,or to the private sector, of $100 millionor more in any one year. Beforepromulgating an EPA rule for which awritten statement is needed, section 205of the UMRA generally requires EPA toidentify and consider a reasonablenumber of regulatory alternatives andadopt the least costly, most costeffective,or least burdensomealternative that achieves the objectivesof the rule. The provisions of section205 do not apply when they areinconsistent with applicable law.Moreover, section 205 allows EPA toadopt an alternative other than the leastcostly, most cost-effective, or leastburdensome alternative if theAdministrator publishes with the finalrule an explanation why that alternativewas not adopted. Before EPA establishesany regulatory requirements that maysignificantly or uniquely affect smallgovernments, including tribalgovernments, it must have developedunder section 203 of the UMRA a smallgovernment agency plan. The plan mustprovide for notifying potentiallyaffected small governments, enablingofficials of affected small governmentsto have meaningful and timely input inthe development of EPA regulatoryproposals with significant Federalintergovernmental mandates, andinforming, educating, and advisingsmall governments on compliance withthe regulatory requirements.EPA has determined that the final ruledoes not contain a Federal mandate thatmay result in expenditures of $100million or more for State, local, andtribal governments, in the aggregate, orthe private sector in any one year. Thus,the final rule is not subject to therequirements of sections 202 and 205 ofthe UMRA. In addition, the final ruledoes not significantly or uniquely affectsmall governments. The final rulecontains no requirements that apply tosuch governments, impose noobligations upon them, and will notresult in expenditures by them of $100million or more in any one year or anydisproportionate impacts on them.Therefore, the final rule is not subject tosection 203 of the UMRA.E. Executive Order 13132: FederalismExecutive Order 13132, entitled‘‘Federalism’’ (64 FR 43255, August 10,1999) requires EPA to develop anaccountable process to ensure‘‘meaningful and timely input by State

73622 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulationspwalker on PROD1PC71 with RULESand local officials in the development ofregulatory policies that have federalismimplications.’’ ‘‘Policies that havefederalism implications’’ is defined inthe Executive Order to includeregulations that have ‘‘substantial directeffects on the States, on the relationshipbetween the national government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government.’’This final rule does not havefederalism implications. It will not havesubstantial direct effects on the States,on the relationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government, as specified inExecutive Order 13132. The final ruleimposes requirements on owners andoperators of specified area sources andnot State and local governments. Thus,Executive Order 13132 does not applyto this final rule.F. Executive Order 13175: Consultationand Coordination With Indian TribalGovernmentsExecutive Order 13175, entitled‘‘Consultation and Coordination withIndian Tribal Governments’’ (65 FR67249, November 9, 2000), requires EPAto develop an accountable process toensure ‘‘meaningful and timely input bytribal officials in the development ofregulatory policies that have tribalimplications.’’ This final rule does nothave tribal implications, as specified inExecutive Order 13175. It will not havesubstantial direct effects on tribalgovernments, on the relationshipbetween the Federal government andIndian tribes, or on the distribution ofpower and responsibilities between theFederal government and Indian tribes,as specified in Executive Order 13175.This final rule imposes requirements onowners and operators of specified areasources and not tribal governments.Thus, Executive Order 13175 does notapply to this final rule.G. Executive Order 13045: Protection ofChildren From Environmental HealthRisks and Safety RisksExecutive Order 13045, ‘‘Protection ofChildren from Environmental HealthRisks and Safety Risks’’ (62 FR 19885,April 23, 1997) applies to any rule that:(1) Is determined to be ‘‘economicallysignificant’’ as defined under ExecutiveOrder 12866, and (2) concerns anenvironmental health or safety risk thatEPA has reason to believe may have adisproportionate effect on children. Ifthe regulatory action meets both criteria,the Agency must evaluate theenvironmental health or safety effects ofthe planned rule on children, andexplain why the planned regulation ispreferable to other potentially effectiveand reasonably feasible alternativesconsidered by the Agency.EPA interprets Executive Order 13045as applying only to those regulatoryactions that are based on health or safetyrisks, such that the analysis requiredunder section 5–501 of the ExecutiveOrder has the potential to influence theregulation. This final rule is not subjectto Executive Order 13045 because it isbased on technology performance andnot on health or safety risks.H. Executive Order 13211: ActionsConcerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or UseThis final rule is not a ‘‘significantenergy action’’ as defined in ExecutiveOrder 13211, ‘‘Actions ConcerningRegulations That Significantly AffectEnergy Supply, Distribution, and Use’’(66 FR 28355, May 22, 2001) because itis not likely to have a significantadverse effect on the supply,distribution, or use of energy. Further,we have concluded that the final rule isnot likely to have any adverse energyeffects because energy requirementswould likely be less than existing levels.No additional pollution controls orother equipment that would consumeenergy are required by this final rule.I. National Technology Transfer andAdvancement ActAs noted in the proposed rule,Section 12(d) of the NationalTechnology Transfer and AdvancementAct (NTTAA) of 1995 (Pub. L. 104–113,12(d) (15 U.S.C. 272 note) directs EPAto use voluntary consensus standards(VCS) in its regulatory activities, unlessto do so would be inconsistent withapplicable law or otherwise impractical.VCS are technical standards (e.g.,materials specifications, test methods,sampling procedures, and businesspractices) that are developed or adoptedby VCS bodies. The NTTAA directs EPAto provide Congress, through OMB,explanations when the Agency decidesnot to use available and applicable VCS.This action does not involve technicalstandards. Therefore, EPA did notconsider the use of any VCS.J. Executive Order 12898: FederalActions to Address EnvironmentalJustice in Minority Populations andLow-Income PopulationsExecutive Order 12898 (59 FR 7629,February 16, 1994) establishes Federalexecutive policy on environmentaljustice. Its main provision directsFederal agencies, to the greatest extentpracticable and permitted by law, tomake environmental justice part of theirmission by identifying and addressing,as appropriate, disproportionately highand adverse human health orenvironmental effects of their programs,policies, and activities on minoritypopulations and low-incomepopulations in the United States.EPA has determined that this finalrule will not have disproportionatelyhigh and adverse human health orenvironmental effects on minority orlow-income populations because itincreases the level of environmentalprotection for all affected populationswithout having any disproportionatelyhigh and adverse human health orenvironmental effects on anypopulation, including any minority orlow-income population. This final ruleestablishes national standards for thearea source category.K. Congressional Review ActThe Congressional Review Act, 5U.S.C. 801, et seq., as added by theSmall Business Regulatory EnforcementFairness Act of 1996, generally providesthat before a rule may take effect, theagency promulgating the rule mustsubmit a rule report, which includes acopy of the rule, to each House of theCongress and to the Comptroller Generalof the United States. EPA will submit areport containing this final rule andother required information to the UnitedStates Senate, the United States Houseof Representatives, and the ComptrollerGeneral of the United States prior topublication of the final rule in theFederal Register. A major rule cannottake effect until 60 days after it ispublished in the Federal Register. Thisaction is not a ‘‘major rule’’ as definedby 5 U.S.C. 804(2). This final rule willbe effective on December 28, 2007.List of Subjects in 40 CFR Part 63Environmental protection, Airpollution control, Hazardoussubstances, Reporting andrecordkeeping requirements.Dated: December 20, 2007.Stephen L. Johnson,Administrator.■ For the reasons stated in the preamble,title 40, chapter I, part 63 of the Codeof Federal Regulations is amended asfollows:PART 63—[AMENDED]VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1■ 1. The authority citation for part 63continues to read as follows:Authority: 42 U.S.C. 7401, et seq.■ 2. Part 63 is amended by addingsubpart WWWWW to read as follows:

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73623pwalker on PROD1PC71 with RULESSubpart WWWWW—National EmissionStandards for Hospital Ethylene OxideSterilizersSec.Applicability and Compliance Dates63.10382 Am I subject to this subpart?63.10384 What are my compliance dates?Standards63.10390 What management practicestandards must I meet?Initial Compliance Requirements63.10400 How do I demonstrate initialcompliance?63.10402 By what date must I demonstrateinitial compliance?Monitoring—Continuous ComplianceRequirements63.10420 How do I demonstratecontinuous compliance with themanagement practice requirements?Notifications, Reports, and Records63.10430 What notifications must I submitand when?63.10432 What records must I keep?63.10434 In what form and for how longmust I keep my records?Other Requirements and Information63.10440 What parts of the GeneralProvisions apply to me?63.10442 Who implements and enforcesthis subpart?63.10446 Do title V permitting requirementsapply to area sources subject to thissubpart?63.10448 What definitions apply to thissubpart?Table to Subpart WWWWW of Part 63Table 1 to Subpart WWWWW of Part 63—Applicability of General Provisions toSubpart WWWWWSubpart WWWWW—National EmissionStandards for Hospital Ethylene OxideSterilizersApplicability and Compliance Dates§ 63.10382 Am I subject to this subpart?(a) You are subject to this subpart ifyou own or operate an ethylene oxidesterilization facility at a hospital that isan area source of hazardous airpollutant (HAP) emissions.(b) The affected source subject to thissubpart is each new or existingsterilization facility.(1) An affected source is existing ifyou commenced construction orreconstruction of the affected sourcebefore November 6, 2006.(2) An affected source is new if youcommenced construction orreconstruction of the affected source onor after November 6, 2006.§ 63.10384 What are my compliancedates?(a) Existing source. If you have anexisting affected source, you mustcomply with applicable requirements inthis subpart no later than December 29,2008.(b) New source. If you start up a newaffected source on or before December28, 2007, you must comply withapplicable requirements in this subpartby December 28, 2007.(c) New source. If you start up a newaffected source after December 28, 2007,you must comply with applicablerequirements in this subpart uponstartup of your affected source.Standards§ 63.10390 What management practicestandard must I meet?You must sterilize full loads of itemshaving a common aeration time, exceptunder medically necessarycircumstances, as that term is defined in§ 63.10448.Initial Compliance Requirements§ 63.10400 How do I demonstrate initialcompliance?(a) Except as provided in paragraphs(b) and (c) of this section, you mustdemonstrate initial compliance with themanagement practice standard in§ 63.10390 by submitting an InitialNotification of Compliance Statuscertifying that you are sterilizing fullloads of items having a commonaeration time except under medicallynecessary circumstances.(b) If you operate your sterilizationunit(s) with an air pollution controldevice pursuant to a State or localregulation, you may demonstrate initialcompliance with § 63.10390 bysubmitting an Initial Notification ofCompliance Status certifying that youare operating the sterilization unit inaccordance with your State or localregulation and following control devicemanufacturer’s recommendedprocedures.(c) If you operate your sterilizationunit(s) with an air pollution controldevice but are not subject to any Stateor local regulation, you maydemonstrate initial compliance with§ 63.10390 by submitting an InitialNotification of Compliance Statuscertifying that you are venting theethylene oxide emissions from eachsterilization unit to an add-on airpollution control device. You mustcertify that you are operating the controldevice during all sterilization processesand in accordance with manufacturer’srecommended procedures.VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1§ 63.10402 By what date must Idemonstrate initial compliance?You must demonstrate initialcompliance with § 63.10390 uponstartup or no later than 180 calendardays after your compliance date,whichever is later.Monitoring—Continuous ComplianceRequirements§ 63.10420 How do I demonstratecontinuous compliance with themanagement practice requirements?For each sterilization unit notequipped with an air pollution controldevice, you must demonstratecontinuous compliance with themanagement practice standard in§ 63.10390 by recording the date andtime of each sterilization cycle, whethereach sterilization cycle contains a fullload of items, and if not, a statementfrom a hospital central services staff, ahospital administrator, or a physicianthat it was medically necessary.Notifications, Reports, and Records§ 63.10430 What notifications must Isubmit and by when?(a) You must submit an InitialNotification of Compliance Status thatincludes the information required inparagraphs (a)(1) through (5) of thissection and the applicable certificationin § 63.10400.(1) The name and address of theowner or operator.(2) The address (i.e., physicallocation) of the affected source.(3) An identification of the standardand other applicable requirements inthis subpart that serve as the basis of thenotification and the source’s compliancedate.(4) A brief description of thesterilization facility, including thenumber of ethylene oxide sterilizers, thesize (volume) of each, the number ofaeration units, if any, the amount ofannual ethylene oxide usage at thefacility, the control technique used foreach sterilizer, and typical number ofsterilization cycles per year.(5) A statement that the affectedsource is an area source.(b) You must submit the InitialNotification of Compliance Status to theappropriate authority(ies) specified in§ 63.9(a)(4). In addition, you mustsubmit a copy of the Initial Notificationof Compliance Status to EPA’s Office ofAir Quality Planning and Standards.Send your notification via e-mail toCCG-ONG@EPA.GOV or via U.S. mail orother mail delivery service to U.S. EPA,Sector Policies and Programs Division,Coatings and Chemicals Group (E143–01), Attn: Hospital Sterilizers Project

73624 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and RegulationsLeader, Research Triangle Park, NC27711.(c) You must submit the InitialNotification of Compliance Status nolater than 180 calendar days after yourcompliance date, consistent with§ 63.10402.§ 63.10432 What records must I keep?You must keep the records specifiedin paragraphs (a) and (b) of this section.(a) A copy of the Initial Notificationof Compliance Status that yousubmitted to comply with this subpart.(b) Records required by § 63.10420 foreach sterilization unit not equippedwith an air pollution control device.§ 63.10434 In what form and for how longmust I keep my records?(a) Your records must be in a formsuitable and readily available forexpeditious review.(b) You must keep each record for 5years following the date of each record.(c) You must keep each record onsitefor at least 2 years after the date of eachrecord. You may keep the records offsitefor the remaining 3 years.Other Requirements and Information§ 63.10440 What parts of the GeneralProvisions apply to me?Table 1 to this subpart shows whichparts of the General Provisions in 40CFR 63.1 through 63.16 apply to you.§ 63.10442 Who implements and enforcesthis subpart?(a) This subpart can be implementedand enforced by us, the U.S. EPA, or adelegated authority such as your State,local, or tribal agency. If the U.S. EPAAdministrator has delegated authority toyour State, local, or tribal agency, thenthat agency has the authority toimplement and enforce this subpart.You should contact your U.S. EPARegional Office to find out if thissubpart is delegated to your State, local,or tribal agency.(b) In delegating implementation andenforcement authority of this subpart toa State, local, or tribal agency under 40CFR part 63, subpart E, the authoritiescontained in paragraph (c) of thissection are retained by theAdministrator of the U.S. EPA and arenot transferred to the State, local, ortribal agency.(c) The authorities that will not bedelegated to State, local, or tribalagencies include approval ofalternatives to the applicabilityrequirements under 40 CFR 63.10382,the compliance date requirements in 40CFR 63.10384, and the managementpractice standards as defined in 40 CFR63.10390.§ 63.10446 Do title V permittingrequirements apply to area sources subjectto this subpart?You are exempt from the obligation toobtain a permit under 40 CFR part 70 or40 CFR part 71, provided you are nototherwise required by law to obtain apermit under 40 CFR 70.3(a) or 40 CFR71.3(a). Notwithstanding the previoussentence, you must continue to complywith the provisions of this subpart.§ 63.10448 What definitions apply to thissubpart?Terms used in this subpart aredefined in the Clean Air Act (CAA), in40 CFR 63.2, and in this section asfollows:Aeration process means any timewhen ethylene oxide is removed fromthe aeration unit through the aerationunit vent or from the combinationsterilization unit through thesterilization unit vent, while aeration oroff-gassing is occurring.Aeration unit means any vessel that isused to facilitate off-gassing of ethyleneoxide.Air pollution control device means acatalytic oxidizer, acid-water scrubber,or any other air pollution controlequipment that reduces the quantity ofethylene oxide in the effluent gas streamfrom sterilization and aerationprocesses.Combination sterilization unit meansany enclosed vessel in which both thesterilization process and the aerationprocess occur within the same vessel,i.e., the vessel is filled with ethyleneoxide gas or an ethylene oxide/inert gasmixture for the purpose of sterilizingand is followed by off-gassing ofethylene oxide.Common aeration time means thatitems require the same length of time tooff-gas ethylene oxide.Full load means the maximumnumber of items that does not impedeproper air removal, humidification ofthe load, or sterilant penetration andevacuation in the sterilization unit.Hospital means a facility thatprovides medical care and treatment forpatients who are acutely ill orchronically ill on an inpatient basisunder supervision of licensedphysicians and under nursing careoffered 24 hours per day. Hospitalsinclude diagnostic and major surgeryfacilities but exclude doctor’s offices,clinics, or other facilities whose primarypurpose is to provide medical servicesto humans or animals on an outpatientbasis.Hospital central services staff means ahealthcare professional, includingmanager and technician, who is eitherdirectly involved in or responsible forsterile processing at a hospital.Medically necessary meanscircumstances that a hospital centralservices staff, a hospital administrator,or a physician concludes, based ongenerally accepted medical practices,necessitate sterilizing without a fullload in order to protect human health.State or local regulation means aregulation at the State or local level thatrequires a hospital to reduce thequantity of ethylene oxide emissionsfrom ethylene oxide sterilization units.Sterilization facility means the groupof ethylene oxide sterilization units at ahospital using ethylene oxide gas or anethylene oxide/inert gas mixture for thepurpose of sterilizing.Sterilization process means any timewhen ethylene oxide is removed fromthe sterilization unit or combinationsterilization unit through thesterilization unit vent.Sterilization unit means any enclosedvessel that is filled with ethylene oxidegas or an ethylene oxide/inert gasmixture for the purpose of sterilizing.As used in this subpart, the termincludes combination sterilization units.Table to Subpart WWWWW of Part 63As required in § 63.10440, you mustcomply with the requirements of theGeneral Provisions (40 CFR part 63,subpart A) shown in the following table:TABLE 1 TO SUBPART WWWWW OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART WWWWWCitationSubjectApplies to subpartWWWWWExplanationpwalker on PROD1PC71 with RULES§ 63.1(a)(1)–(4), (6), (10)–(12), (b)(1), (3) Applicability ............................................ Yes.§ 63.1(a)(5), (7)–(9) ................................. [Reserved].§ 63.1(b)(2) .............................................. [Reserved].VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1

Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations73625TABLE 1 TO SUBPART WWWWW OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART WWWWW—ContinuedCitationSubjectApplies to subpartWWWWWExplanation§ 63.1(c)(1)–(2) ........................................ Applicability of this part after a relevantstandard has been set.Yes ...................§ 63.10446 of this subpart exempts affectedsources from the obligation toobtain title V operating permits forpurposes of being subject to this subpart.§ 63.1(c)(3)–(4) ........................................ [Reserved].§ 63.1(c)(5) .............................................. Subject to notification requirements ...... No.§ 63.1(d) ................................................... [Reserved].§ 63.1(e) ................................................... Emission limitation by permit ................. Yes.§ 63.2 ....................................................... Definitions .............................................. Yes.§ 63.3 ....................................................... Units and abbreviations ......................... Yes.§ 63.4 ....................................................... Prohibited activities ................................ Yes.§ 63.5 ....................................................... Construction/reconstruction ................... No.§ 63.6(a), (b)(1)–(5), (7) ........................... Compliance with standards and mainte-Yes.nance requirements.§ 63.6(b)(6) .............................................. [Reserved].§ 63.6(c)(1) .............................................. Compliance dates for existing sources .. Yes ................... Subpart WWWWW requires compliance1 year after the effective date.§ 63.6(c)(2), (5) ........................................ Compliance dates for CAA section112(f) standards and for area sourcesthat become major.§ 63.6(c)(3)–(4) ........................................ [Reserved].§ 63.6(d) ................................................... [Reserved].§ 63.6(e)–(h) ............................................ Alternative nonopacity emission standard.§ 63.6(i)–(j) ............................................... Compliance extension ............................ Yes.§ 63.7 ....................................................... Performance testing requirements ......... No.§ 63.8 ....................................................... Monitoring requirements ........................ No.§ 63.9(a) ................................................... Applicability and initial notifications addressees.Yes.§ 63.9(b) ................................................... Initial notifications ................................... No.§ 63.9(c) ................................................... Request for extension of compliance .... Yes.§ 63.9(d)–(j) ............................................. Other notifications .................................. No.§ 63.10(a)(1)–(2) ...................................... Recordkeeping and reporting requirements,Yes.applicability.§ 63.10(a)(3)–(4) ...................................... General information ............................... Yes.§ 63.10(a)(5)–(7) ...................................... Recordkeeping and reporting requirements,No.reporting schedules.§ 63.10(b)(1) ............................................ Retention time ........................................ Yes.§ 63.10(b)(2)–(f) ....................................... Recordkeeping and reporting requirements.No.§ 63.11 ..................................................... Control device requirements .................. No.§ 63.12 ..................................................... State authority and delegations ............. Yes.§§ 63.13–63.16 ........................................ Addresses, Incorporations by Reference,Yes.availability of information,performance track provisions.No.No.pwalker on PROD1PC71 with RULES[FR Doc. E7–25233 Filed 12–27–07; 8:45 am]BILLING CODE 6560–50–PENVIRONMENTAL PROTECTIONAGENCY40 CFR Part 65[EPA–HQ–OAR–2007–0429; FRL–8511–7]RIN 2060–A045Revisions to Consolidated Federal AirRule; CorrectionAGENCY: Environmental ProtectionAgency (EPA).ACTION: Correcting amendments.SUMMARY: The EPA issued a final ruleon August 27, 2007 (effective dateNovember 26, 2007) that revised theGeneral Provisions for ConsolidatedFederal Air Rule to allow extensions tothe deadline imposed for source ownersand operators to conduct requiredperformance tests in specified forcemajeure circumstances. The final ruleinadvertently stated that we wererevising paragraph (c) introductory textwhen we actually added introductorytext to paragraph (c). The purpose ofthis action is to correct this error.This action merely addresses aformatting issue. Thus, it is proper toissue this notice without notice andcomment. Section 553 of theAdministrative Procedure Act (APA), 5VerDate Aug2005 23:53 Dec 27, 2007 Jkt 214001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1U.S.C. 553(b)(B), provides that, when anAgency for good cause finds that noticeand public procedure are impracticable,unnecessary, or contrary to the publicinterest, the Agency may issue a rulewithout providing notice and anopportunity for public comment. Wehave determined that there is goodcause for making this action finalwithout prior proposal and opportunityfor comment because the change to therule is a minor technical correction, isnoncontroversial, and does notsubstantively change the agency actionstaken in the final rule. Thus, notice andpublic procedure are unnecessary. Wefind that this constitutes good causeunder 5 U.S.C. 553(b)(B).