<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-07-26-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AG36</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201104</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Hazard Analysis and Risk-Based Preventive Controls</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) Food Safety Modernization Act (the FSMA) requires the Secretary of Health and Human Services to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls; and to define the terms 'small business' and 'very small business.' The FSMA also requires the Secretary to promulgate regulations with respect to activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on a farm or another farm under the same ownership and activities that constitute on farm manufacturing or processing of food that is not grown, raised, or consumed on a farm or another farm under the same ownership.

FDA is proposing to amend its current good manufacturing practice (CGMP) regulations (21 CFR Part 110) for manufacturing, packing, or holding human food to require food facilities to develop and implement a written food safety plan.  This proposed rule would require a food facility to have and implement preventive controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility and to provide assurances that such food will not be adulterated under section 402 or misbranded under section 403(w).]]></ABSTRACT>
        <PRIORITY_CATEGORY>Economically Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Yes</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 110</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 342</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 264</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>PL 111-353, (signed on January 4, 2011)</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Final</DLINE_ACTION_STAGE>
                <DLINE_DATE>07/04/2012</DLINE_DATE>
                <DLINE_DESC>Final rule must be published no later than 18 months after the date of enactment of the FDA Food Safety Modernizaton Act.</DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <LEGAL_DLINE_OVERALL_DESC>Not later than 9 months after the date of enactment of the FDA Food Safety Modernization Act.  </LEGAL_DLINE_OVERALL_DESC>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>10/00/2011</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>Undetermined</FEDERALISM>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>John</FIRST_NAME>
                <LAST_NAME>Sheehan</LAST_NAME>
                <MIDDLE_NAME>F.</MIDDLE_NAME>
                <TITLE>Director, Office of Food Safety, Division of Plant and Dairy Food Safety</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>240 402-1488</PHONE>
                <FAX>301 436-2632</FAX>
                <EMAIL>john.sheehan@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Food Safety and Applied Nutrition (HFS-315), 5100 Paint Branch Parkway ,</STREET_ADDRESS>
                    <CITY>College Park</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20740</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
