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

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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).
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