/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).
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.
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
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.
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.
FOR FURTHER INFORMATION CONTACT
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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