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 Tuesday,December 2, 2008
Part IV 
Environmental Protection Agency 
40 CFR Part 260, 261, 264, et al. Amendment to the Universal Waste Rule: Addition of Pharmaceuticals; Proposed Rule
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Federal Register
/Vol. 73, No. 232/Tuesday, December 2, 2008/Proposed Rules
ENVIRONMENTAL PROTECTIONAGENCY40 CFR Part 260, 261, 264, 265, 268,270 and 273
[EPA–HQ–RCRA–2007–0932; FRL–8746–2]RIN 2050–AG39
Amendment to the Universal WasteRule: Addition of Pharmaceuticals
Environmental ProtectionAgency (EPA).
Proposed rule.
EPA is proposing to addhazardous pharmaceutical wastes to theUniversal Waste Rule. The UniversalWaste Rule, originally promulgated onMay 11, 1995, modified the ResourceConservation and Recovery Act’shazardous waste regulations byestablishing a set of streamlinedrequirements for the collection of certain widely dispersed hazardouswastes, called ‘‘universal wastes.’’ Thisproposed rule would facilitate bettermanagement of pharmaceutical wastes by streamlining the generatorrequirements and encouraginggenerators of hazardous pharmaceuticalwastes to manage them under theprovisions of the Universal Waste Rule,which ensures that these hazardouspharmaceutical wastes are properlydisposed of and treated as hazardouswastes. In addition, this proposed rulewould facilitate the implementation of pharmaceutical take-back programs byremoving RCRA barriers in thecollection of pharmaceutical wastesfrom health care and other suchregulated facilities, as well as facilitatethe collection of pharmaceutical wastesfrom households, including non-hazardous pharmaceutical wastes.
Comments must be received onor before February 2, 2009. Under thePaperwork Reduction Act, since theOffice of Management and Budget(OMB) is required to make a decisionconcerning the Information CollectionRequest (ICR) between 30 and 60 daysafter December 2, 2008, a comment toOMB is best assured of having its fulleffect if OMB receives it by January 2,2009.
Submit your comments,identified by Docket ID No. EPA–HQ–RCRA–2007–0932, by one of thefollowing methods:
Followthe on-line instructions for submittingcomments.
RCRA Docket, EnvironmentalProtection Agency, Mailcode: 2822T,1200 Pennsylvania Ave., NW.,Washington, DC 20460. In addition,please mail a copy of your comments onthe information collection provisions tothe Office of Information and RegulatoryAffairs, Office of Management andBudget (OMB), Attn: Desk Officer forEPA, 725 17th St., NW., Washington, DC20503.
Hand Delivery:
EPA West Building,Room 3334, 1301 Constitution Avenue,NW., Washington, DC 20460. Suchdeliveries are only accepted during theDocket’s normal hours of operation, andspecial arrangements should be madefor deliveries of boxed information.
Direct your comments toDocket ID No. EPA–HQ–RCRA–2007–0932. EPA’s policy is that all commentsreceived will be included in the publicdocket without change and may bemade available online at
including anypersonal information provided, unlessthe comment includes informationclaimed to be Confidential BusinessInformation (CBI) or other informationwhose disclosure is restricted by statute.Do not submit information that youconsider to be CBI or otherwiseprotected through
or e-mail. The
Web site isan ‘‘anonymous access’’ system, whichmeans EPA will not know your identityor contact information unless youprovide it in the body of your comment.If you send an e-mail comment directlyto EPA without going through
your e-mailaddress will be automatically capturedand included as part of the commentthat is placed in the public docket andmade available on the Internet. If yousubmit an electronic comment, EPArecommends that you include yourname and other contact information inthe body of your comment and with anydisk or CD–ROM you submit. If EPAcannot read your comment due totechnical difficulties and cannot contactyou for clarification, EPA may not beable to consider your comment.Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects orviruses. For additional informationabout EPA’s public docket, visit the EPADocket Center homepage at
For additional instructions onsubmitting comments, go to the
section of this document.
All documents in the docketare listed in the
index. Althoughlisted in the index, some information isnot publicly available, e.g., CBI or otherinformation whose disclosure isrestricted by statute. Certain othermaterial, such as copyrighted material,will be publicly available only in hardcopy. Publicly available docketmaterials are available eitherelectronically in
or in hard copy atthe RCRA Docket, EPA/DC, EPA West,Room 3334, 1301 Constitution Ave.,NW., Washington, DC. The PublicReading Room is open from 8:30 a.m. to4:30 p.m., Monday through Friday,excluding legal holidays. The telephonenumber for the Public Reading Room is(202) 566–1744, and the telephonenumber for the RCRA Docket is (202)566–0270.
LisaLauer, Office of Solid Waste (5304P),Environmental Protection Agency, 1200Pennsylvania Avenue, NW.,Washington, DC 20460; telephonenumber: 703–308–7418; fax number:703–605–0595; e-mail address
I. General Information
A. Does This Action Apply to Me? 
This proposed rule could affect up to634,552 entities in approximately 10industries involved in health careand/or management of hazardouspharmaceutical wastes, as defined inthis proposed rule. This includespharmacies, hospitals, physicians’offices, dentists’ offices, other healthcare practitioners, outpatient carecenters, ambulatory health care services,residential care facilities, veterinaryclinics and reverse distributors. Of theseentities, EPA’s Biennial ReportingSystem (BRS) indicates thatapproximately 181 are large quantitygenerators (LQGs) of hazardous waste.The remainder are likely to be eithersmall quantity generators (SQGs) orconditionally-exempt small quantitygenerators (CESQGs). Under thisproposal, hazardous pharmaceuticalwaste generators may elect to have theirhazardous pharmaceutical waste remainregulated under the current ResourceConservation and Recovery Act (RCRA)generator regulations as set forth in 40CFR part 262, or may choose to managetheir hazardous pharmaceutical wastesunder the Universal Waste Rule (UWR).In RCRA-authorized states, the option of managing hazardous pharmaceuticalwaste under this proposal would beavailable once it has been adopted bythe state.
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Federal Register
/Vol. 73, No. 232/Tuesday, December 2, 2008/Proposed Rules
B. What Should I Consider as I PrepareMy Comments for EPA? 
Submitting CBI.
Do not submit thisinformation to EPA through
or e-mail. Clearlymark the part or all of the informationthat you claim to be CBI. For CBIinformation in a disk or CD ROM thatyou mail to EPA, mark the outside of thedisk or CD ROM as CBI and thenidentify electronically within the disk orCD ROM the specific information that isclaimed as CBI. In addition to onecomplete version of the comment thatincludes information claimed as CBI, acopy of the comment that does notcontain the information claimed as CBImust be submitted for inclusion in thepublic docket. Information so markedwill not be disclosed except inaccordance with the procedures setforth in 40 CFR part 2.2.
Tips for Preparing Your Comments.
When submitting comments, rememberto:
Identify the rulemaking by docketnumber and other identifyinginformation (subject heading,
date and page number).
Follow directions—The agency mayask you to respond to specific questionsor organize comments by referencing aCode of Federal Regulations (CFR) partor section number.
Explain why you agree or disagree,suggest alternatives, and substitutelanguage for your requested changes.
Describe any assumptions andprovide any technical informationand/or data that you used.
If you estimate potential costs or burdens, explain how you arrived atyour estimate in sufficient detail toallow for it to be reproduced.
Provide specific examples toillustrate your concerns, and suggestalternatives.
Explain your views as clearly aspossible.
Make sure to submit yourcomments by the comment perioddeadline identified.3.
Docket Copying Costs.
Manydocuments are available only in theoriginal and, therefore, must bephotocopied. Patrons are allowed 100free photocopies. Thereafter they arecharged 15 cents per page. Whennecessary, an invoice stating how manycopies were made, the cost of the order,and where to send a check will beissued to the patron.Documents also are available onmicrofilm. The EPA/DC staff helppatrons locate needed documents andoperate the microfilm machines. The billing fee for printing microfilmdocuments is the same as forphotocopying documents.Patrons who are outside of themetropolitan Washington, DC, area canrequest documents by telephone. Thephotocopying and microfilming fee isthe same as for walk-in patrons. If aninvoice is necessary, EPA/DC staff canmail one with the order.
Preamble Outline
I. Statutory AuthorityII. List of Abbreviations and AcronymsIII. IntroductionIV. BackgroundA. What Are the Current RCRA GeneratorRequirements Governing HazardousPharmaceutical Waste?B. How Are ‘‘Pharmaceutical’’ and‘‘Pharmaceutical Universal Waste’’Defined in this Proposal?C. How Do the Current RCRA HazardousWaste Regulations Apply to Generatorsof Pharmaceutical Waste?1. Determining Whether PharmaceuticalWaste Is Subject to the Hazardous WasteRegulations2. Which Sources May Generate HazardousPharmaceutical Waste Subject to ThisProposal?a. Health Care Facilities b. Pharmaciesc. Long-Term Care Facilitiesd. Reverse Distributors of Pharmaceuticalse. Pharmaceutical Take-Back ProgramsD. Why Is Management of PharmaceuticalWaste Difficult Under the RCRA SubtitleC Hazardous Waste Regulations?1. Waste Determination2. Change in Generator Status FromConditionally Exempt Small QuantityGenerators to Large Quantity GeneratorsDue to Generation of Acutely HazardousWastes3. Accumulation Time LimitsE. What Is the Universal Waste Rule?F. Why Is Pharmaceutical WasteAppropriate for Inclusion in theUniversal Waste Framework?G. How Will Adding HazardousPharmaceutical Waste to the UniversalWaste Rule Help AddressPharmaceutical Waste ManagementIssues?1. Application of the Universal Waste Ruleto Pharmaceutical Wastesa. Waste Determination b. Accumulation Time and GenerationVolume LimitsV. Detailed Discussion of This Proposed RuleA. Intent and Purpose of This ProposedRuleB. Applicability1. RCRA Hazardous Pharmaceutical Wastes2. Households and Conditionally ExemptSmall Quantity Generators3. Handlers of Universal Wastea. Small Quantity Handlers of UniversalWaste b. Large Quantity Handlers of UniversalWasteC. DefinitionsD. Waste Management1. Containers2. Sorting3. Generation of Solid WastesE. Labeling/MarkingF. Accumulation Time LimitsG. Employee TrainingH. Responses to ReleasesI. Off-Site Shipments J. Tracking Universal Waste ShipmentsK. ExportsL. Standards for Universal WasteTransportersM. Standards for Destination FacilitiesN. Import RequirementsO. Land Disposal RestrictionsVI. State AuthorityA. Applicability of Rule in AuthorizedStatesB. Effect on State AuthorizationVII. 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 of Children From Environmental Healthand Safety RisksH. Executive Order 13211: Actions ThatSignificantly Affect Energy Supply,Distribution or UsageI. National Technology TransferAdvancement Act J. Executive Order 12898: Federal Actionsto Address Environmental Justice inMinority Populations and Low-IncomePopulations
I. Statutory Authority
These regulations are proposed underthe authority of sections 2002(a), 3001,3002, 3004, and 3006 of the Solid WasteDisposal Act of 1970, as amended by theResource Conservation and RecoveryAct of 1976 (RCRA), and as amended bythe Hazardous and Solid WasteAmendments of 1984 (HSWA), 42U.S.C. 6912(a), 6921, 6922, 6923, 6924,6926, 6927, 6930 and 6937.
II. List of Abbreviations and Acronyms
AEAAtomic Energy Act of 1954BRSBiennial Reporting SystemCERCLAComprehensive EnvironmentalResponse, Compensation, and LiabilityActCESQGConditionally Exempt SmallQuantity GeneratorCFRCode of Federal RegulationsCIVSchedule IV Controlled SubstanceCWAClean Water ActDEADrug Enforcement AdministrationDOEDepartment of EnergyDOTDepartment of TransportationEPAEnvironmental Protection AgencyFDAFood and Drug AdministrationHIPAAHealth Insurance Portability andAccountability ActHSWAHazardous and Solid WasteAmendments of 1984IVIntravenousLD50Lethal Dose 50%LDRLand Disposal RestrictionsLQGLarge Quantity GeneratorLQHUWLarge Quantity Handler of Universal Waste
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