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

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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 <strong>Environmental</strong>, 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
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