<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-30-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>2070-AJ65</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201010</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>General Exemptions From Reporting Requirements for Microorganisms; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions</RULE_TITLE>
        <ABSTRACT><![CDATA[In 1997, EPA promulgated a final rule under section 5 of Toxics Substances and Control Act (TSCA) to establish the notification procedures for review of certain new microorganisms before they are introduced into commerce. New microorganisms are those formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. This review process is designed to prevent unreasonable risk of injury to human health and the environment without imposing unnecessary regulatory burdens on the biotechnology industry. The rule also established TSCA section 5(h)(4) exemptions from full reporting when 10 specific microorganisms are used as the recipient microorganisms for the introduced genetic material and placed requirements on these recipient microorganism, the introduced genetic material, and the physical containment (40 CFR 725, subpart G). The rule also established a mechanism (40 CFR 725.67) for the public to petition the Agency to propose additional recipient microorganisms for such exemptions. These regulations describe the appropriate supporting information that must be submitted with the petition to provide EPA with a starting point for determining whether the recipient should be listed as a candidate for the tiered exemption. EPA has received petitions to add two additional microorganisms to the eligible recipient microorganisms listed in 40 CFR 725.420 (Trichoderma reesei and Bacillus amyloliquefaciens). EPA is evaluating the information provided in these petitions. If, as result of this evaluation, EPA makes a preliminary determination that one or both of the two microorganisms will not present an unreasonable risk of injury to health or the environment, then EPA will propose a rule to grant the exemption petition for that microorganism(s).]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</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>Not Yet Determined</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>15 USC 2601 et seq.</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>03/00/2011</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>SAN No. 5418</ADDITIONAL_INFO>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <FURTHER_INFO_URL>http://www.epa.gov/oppt/</FURTHER_INFO_URL>
        <NAICS_LIST>
            <NAICS>
                <NAICS_CD>325</NAICS_CD>
                <NAICS_DESC>Chemical Manufacturing</NAICS_DESC>
            </NAICS>
        </NAICS_LIST>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Miriam</FIRST_NAME>
                <LAST_NAME>Wigginslewis</LAST_NAME>
                <AGENCY>
                    <CODE>2070</CODE>
                    <NAME>Office of Chemical Safety and Pollution Prevention</NAME>
                    <ACRONYM>OCSPP</ACRONYM>
                </AGENCY>
                <PHONE>202 564-9373</PHONE>
                <EMAIL>wigginslewis.miriam@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>7405M,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
            <CONTACT>
                <FIRST_NAME>Greg</FIRST_NAME>
                <LAST_NAME>Schweer</LAST_NAME>
                <AGENCY>
                    <CODE>2070</CODE>
                    <NAME>Office of Chemical Safety and Pollution Prevention</NAME>
                    <ACRONYM>OCSPP</ACRONYM>
                </AGENCY>
                <PHONE>202 564-8469</PHONE>
                <FAX>202 564-9094</FAX>
                <EMAIL>schweer.greg@epa.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>1200 Pennsylvania Avenue NW, Mail Code 7405M,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20460</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
