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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-03-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>2050-AG39</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201404</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>2050</CODE>
            <NAME>Solid Waste and Emergency Response</NAME>
            <ACRONYM>SWER</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>2000</CODE>
            <NAME>Environmental Protection Agency</NAME>
            <ACRONYM>EPA</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Management Standards for Hazardous Waste Pharmaceuticals</RULE_TITLE>
        <ABSTRACT><![CDATA[A small portion of pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act when discarded. Healthcare (and associated) facilities that generate hazardous waste pharmaceuticals have reported having difficulties complying with the manufacturing-oriented framework of the subtitle C hazardous waste regulations for a number of reasons. First, under the current hazardous waste regulatory scheme, healthcare workers, whose primary focus is to provide care for patients, are often involved in the implementation of the regulations. Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are stringently regulated even in small amounts. To facilitate compliance and to respond to these concerns, EPA is proposing to revise the regulations to improve management and disposal of hazardous waste pharmaceuticals. The revisions are also intended to clarify regulation of a major mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution. In 2008, the Agency proposed to address pharmaceutical hazardous waste management issues by adding them to the Universal Waste rule. However, in order to address the adverse comments received on the 2008 proposal, EPA is now considering re-proposing healthcare facility-specific regulations for the management of hazardous  waste pharmaceuticals in order to provide a regulatory scheme that is adapted to the unique issues that hospitals, pharmacies and other healthcare-related facilities face.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>40 CFR 260</CFR>
            <CFR>40 CFR 261</CFR>
            <CFR>40 CFR 262</CFR>
            <CFR>40 CFR 264</CFR>
            <CFR>40 CFR 265</CFR>
            <CFR>40 CFR 266</CFR>
            <CFR>40 CFR 268</CFR>
            <CFR>40 CFR 270</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 USC 6912(a)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 6921-6939</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/02/2008</TTBL_DATE>
                <FR_CITATION>73 FR 73520</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Second NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2014</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Docket #:EPA-HQ-RCRA-2007-0932</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Undetermined</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <FURTHER_INFO_URL>http://www.epa.gov/waste/hazard/generation/pharmaceuticals.htm</FURTHER_INFO_URL>
        <PUBLIC_COMMENT_URL>NPRM: http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.pdf</PUBLIC_COMMENT_URL>
        <NAICS_LIST>
            <NAICS>
                <NAICS_CD>446110</NAICS_CD>
                <NAICS_DESC>Pharmacies and Drug Stores</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>541940</NAICS_CD>
                <NAICS_DESC>Veterinary Services</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562111</NAICS_CD>
                <NAICS_DESC>Solid Waste Collection</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562112</NAICS_CD>
                <NAICS_DESC>Hazardous Waste Collection</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562119</NAICS_CD>
                <NAICS_DESC>Other Waste Collection</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562211</NAICS_CD>
                <NAICS_DESC>Hazardous Waste Treatment and Disposal</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562212</NAICS_CD>
                <NAICS_DESC>Solid Waste Landfill</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562213</NAICS_CD>
                <NAICS_DESC>Solid Waste Combustors and Incinerators</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>562219</NAICS_CD>
                <NAICS_DESC>Other Nonhazardous Waste Treatment and Disposal</NAICS_DESC>
            </NAICS>
            <NAICS>
                <NAICS_CD>622110</NAICS_CD>
                <NAICS_DESC>General Medical and Surgical Hospitals</NAICS_DESC>
            </NAICS>
        </NAICS_LIST>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Mary</FIRST_NAME>
                <LAST_NAME>Jackson</LAST_NAME>
                <AGENCY>
                    <CODE>2050</CODE>
                    <NAME>Office of Land and Emergency Management</NAME>
                    <ACRONYM>OLEM</ACRONYM>
                </AGENCY>
                <PHONE>703 308-8453</PHONE>
                <EMAIL>jackson.mary@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>1200 Pennsylvania Avenue NW, Mail Code 5304P,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
            <CONTACT>
                <FIRST_NAME>Kristin</FIRST_NAME>
                <LAST_NAME>Fitzgerald</LAST_NAME>
                <AGENCY>
                    <CODE>2050</CODE>
                    <NAME>Office of Land and Emergency Management</NAME>
                    <ACRONYM>OLEM</ACRONYM>
                </AGENCY>
                <PHONE>703 308-8286</PHONE>
                <FAX>703 308-0514</FAX>
                <EMAIL>fitzgerald.kristin@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>1200 Pennsylvania Avenue NW, Mail Code 5304P,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
