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    <RIN_INFO>
        <RIN>2070-AJ76</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201210</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>2070</CODE>
            <NAME>Office of Chemical Safety and Pollution Prevention</NAME>
            <ACRONYM>OCSPP</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>2000</CODE>
            <NAME>Environmental Protection Agency</NAME>
            <ACRONYM>EPA</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Protections for Subjects in Human Research Involving Pesticides</RULE_TITLE>
        <ABSTRACT><![CDATA[Under a settlement agreement resolving litigation on EPA's 2006 rule regarding protections for subjects in human research involving pesticides, EPA proposed changes in January 2011 that included broadening the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers; disallowing participation in third-party pesticide studies by subjects who cannot consent for themselves; and identifying considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>40 CFR 26</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>PL 109-54</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>sec 201</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>5 USC 301</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 300(v)-1(b)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>7 USC 136 to 136(y)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 346(a)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Judicial</DLINE_TYPE>
                <DLINE_ACTION_STAGE>NPRM</DLINE_ACTION_STAGE>
                <DLINE_DATE>01/18/2011</DLINE_DATE>
                <DLINE_DESC>Settlement Agreement Deadline for the Administrator&apos;s Signature</DLINE_DESC>
            </LEGAL_DLINE_INFO>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Judicial</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Final</DLINE_ACTION_STAGE>
                <DLINE_DATE>12/18/2011</DLINE_DATE>
                <DLINE_DESC>settlement deadline requires expedited schedule</DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>02/02/2011</TTBL_DATE>
                <FR_CITATION>76 FR 5735</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Rule</TTBL_ACTION>
                <TTBL_DATE>02/00/2013</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Docket #:EPA-HQ-OPP-2010-0785. NPRM Settlement Agreement: 01/18/2011; Settlement Agreement Final Rule: 12/18/2011.</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Federal</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <FURTHER_INFO_URL>http://www.epa.gov/oppfead1/guidance/human-test.htm</FURTHER_INFO_URL>
        <NAICS_LIST>
            <NAICS>
                <NAICS_CD>325320</NAICS_CD>
                <NAICS_DESC>Pesticide and Other Agricultural Chemical Manufacturing</NAICS_DESC>
            </NAICS>
        </NAICS_LIST>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Kelly</FIRST_NAME>
                <LAST_NAME>Sherman</LAST_NAME>
                <AGENCY>
                    <CODE>2070</CODE>
                    <NAME>Office of Chemical Safety and Pollution Prevention</NAME>
                    <ACRONYM>OCSPP</ACRONYM>
                </AGENCY>
                <PHONE>703 305-8401</PHONE>
                <FAX>703 308-7042</FAX>
                <EMAIL>sherman.kelly@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>7501P,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
            <CONTACT>
                <FIRST_NAME>William</FIRST_NAME>
                <LAST_NAME>Jordan</LAST_NAME>
                <AGENCY>
                    <CODE>2070</CODE>
                    <NAME>Office of Chemical Safety and Pollution Prevention</NAME>
                    <ACRONYM>OCSPP</ACRONYM>
                </AGENCY>
                <PHONE>703 305-1049</PHONE>
                <FAX>703 308-4776</FAX>
                <EMAIL>Jordan.William@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>7501P,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
