Food Safety Modernization Act (FSMA)

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main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Food Safety Modernization Act (FSMA)</h1> <div class="lcds-toolbar lcds-toolbar--social"> <a href="#subscribe" class="btn btn-sm btn-default header-button-subscribe">Subscribe to Email Updates</a> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Ffood%2Fguidance-regulation-food-and-dietary-supplements%2Ffood-safety-modernization-act-fsma" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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loading="lazy" src="/files/styles/main_image_1/public/fsma-main-page-crop.jpg?itok=-jmUSfaf" alt="Food Safety Modernization Act (FSMA)" title="Food Safety Modernization Act (FSMA)" class="img-responsive"> </div> <p style="margin-top: 20px;">About 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.</p> <p><strong><a href="/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma" target>The FDA Food Safety Modernization Act (FSMA)</a> </strong>is transforming the nation鈥檚 food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.</p> <p>FDA has finalized several rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.</p> <div title="Rules and Programs" open="yes" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228e885"> <h2 class="panel-title"> <a role="button" data-toggle="collapse" data-parent href="#67469e228e885" aria-controls="67469e228e885">Rules and Programs</a> </h2> </div> <div id="67469e228e885" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="heading_67469e228e885"> <div class="panel-body">   <h2 style="margin-top: -20px;">Rules</h2> <ul> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d338b718-38a6-4649-ab80-c1dd097467d7" href="/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety" title="FSMA Final Rule on Produce Safety">Produce Safety (Final Rule)</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0701768e-bf66-486c-84f3-479b0df55bfb" href="/food/food-safety-modernization-act-fsma/fsma-final-rule-pre-harvest-agricultural-water" title="FSMA Final Rule on Pre-Harvest Agricultural Water ">Pre-Harvest Agricultural Water (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification" target>Accredited Third-Party Certification (Final Rule)</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4213792d-c067-4ad6-b946-4b34f3353f3b" href="/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods" title="FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods">Food Traceability (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals" target>Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (Final Rule)</a></p> </li> <li> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1009675e-40c7-45b7-872a-ea43c22fa033" href="/food/food-safety-modernization-act-fsma/laboratory-accreditation-analyses-foods-laaf-program-final-rule" title="Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule">Laboratory Accreditation for Analyses of Foods (LAAF) (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-mitigation-strategies-protect-food-against-intentional-adulteration" target>Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-human-food" target>Preventive Controls for Human Foods (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food" target>Preventive Controls for Animal Food (Final Rule)</a></p> </li> <li> <p><a href="/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food" target>Sanitary Transportation of Human and Animal Food (Final Rule)</a></p> </li> </ul> <p><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="401187a5-f160-4d98-bf6b-0b0145c4e8c9" href="/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry" title="FSMA Rules & Guidance for Industry">Additional Rules</a></p> <h2>Programs </h2> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7d6730cf-bb72-4022-aa49-bef18f84e48f" href="/food/importing-food-products-united-states/accredited-third-party-certification-program" title="Accredited Third-Party Certification Program">Accredited Third-Party Certification Program</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bf1ae3a0-fc3c-4f18-939e-938cc9532508" href="/food/importing-food-products-united-states/foreign-suppliers-verification-programs-fsvp-list-participants" title="Foreign Suppliers Verification Programs (FSVP) - List of Participants">Foreign Suppliers Verification Programs (FSVP) - List of Participants</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8b348651-a51e-4224-b95f-d4de9b6efd94" href="/food/importing-food-products-united-states/foreign-suppliers-verification-programs-fsvp-importer-portal-records-submission" title="Foreign Suppliers Verification Programs (FSVP) - Importer Portal for Records Submission ">Foreign Suppliers Verification Programs (FSVP) - Importer Portal for Records Submission</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1009675e-40c7-45b7-872a-ea43c22fa033" href="/food/food-safety-modernization-act-fsma/laboratory-accreditation-analyses-foods-laaf-program-final-rule" title="Laboratory Accreditation for Analyses of Foods (LAAF) Program & Final Rule">Laboratory Accreditation for Analyses of Foods Program (LAAF)</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cae7e08a-0698-4f51-b0a4-a91a1ab931af" href="/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip" title="Voluntary Qualified Importer Program (VQIP)">Voluntary Qualified Importer Program (VQIP)</a></li> </ul> </div> </div> </div> <div title="Full Text of FSMA Related Rules" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f26e"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f26e" aria-controls="67469e228f26e">Full Text of FSMA Related Rules</a> </h2> </div> <div id="67469e228f26e" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f26e"> <div class="panel-body">   <p><a href="/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules" target>Searchable list of all FSMA related Rules</a></p> </div> </div> </div> <div title="Guidance Documents" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f328"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f328" aria-controls="67469e228f328">Guidance Documents</a> </h2> </div> <div id="67469e228f328" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f328"> <div class="panel-body">   <p><a href="/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#guidance" target>Searchable list of FSMA related Guidance</a></p> </div> </div> </div> <div title="Training and Technical Assistance" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f3c1"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f3c1" aria-controls="67469e228f3c1">Training and Technical Assistance</a> </h2> </div> <div id="67469e228f3c1" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f3c1"> <div class="panel-body">   <ul> <li><a href="/food/food-safety-modernization-act-fsma/federalstate-integration" target>Federal/State Integration</a></li> <li><a href="/food/food-safety-modernization-act-fsma/food-safety-preventive-controls-alliance" target>Food Safety Preventive Controls Alliance</a> <ul> <li><a href="https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-animal-food" target="_blank">FSPCA Preventive Controls for Animal Food</a> </li> <li><a href="https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-human-food" target="_blank">FSPCA Preventive Controls for Human Food</a></li> <li><a href="https://www.ifsh.iit.edu/fspca/courses/foreign-supplier-verification-programs-fsvp" target="_blank">Foreign Supplier Verification Programs (FSVP)</a></li> <li><a href="https://www.ifsh.iit.edu/fspca/courses/intentional-adulteration" target="_blank">Intentional Adulteration</a></li> </ul> </li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-training" target>Training Framework</a></li> <li><a href="/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma" target>Frequently Asked Questions on FSMA</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-collaborative-training-forum" target>FSMA Collaborative Training Forum</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-technical-assistance-network-tan" target>FSMA Technical Assistance Network (TAN)</a></li> <li><a href="http://international.jifsan.umd.edu/catalogue/course/pip" target="_blank">Produce International Partnership (PIP)</a></li> <li><a href="https://producesafetyalliance.cornell.edu/" target="_blank">Produce Safety Alliance</a></li> <li><a href="/food/food-safety-modernization-act-fsma/produce-safety-network" target>Produce Safety Network</a></li> <li><a href="/food/food-safety-modernization-act-fsma/training-carriers-covered-sanitary-transportation-human-and-animal-food-rule" target>Sanitary Transportation Carriers Training Module</a></li> <li><a href="/food/food-safety-modernization-act-fsma/sprout-safety-alliance" target>Sprout Safety Alliance</a></li> </ul> </div> </div> </div> <div title="Compliance and Implementation Tools" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f45f"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f45f" aria-controls="67469e228f45f">Compliance and Implementation Tools</a> </h2> </div> <div id="67469e228f45f" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f45f"> <div class="panel-body">   <ul> <li><a href="https://www.access.fda.gov/" target="_blank">Application Portal</a></li> <li><a href="/food-code" target>FDA Food Code</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fees" target>Fees</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fda-fsma-and-small-business" target>Small Business</a></li> <li><a href="/food/food-safety-modernization-act-fsma/international-capacity-building" target>International Capacity Building</a></li> <li><a href="/food/tools-educational-materials/food-defense-plan-builder" target>Food Defense Plan Builder</a></li> <li><a href="/food/food-safety-modernization-act-fsma/food-safety-plan-builder" target>Food Safety Plan Builder</a></li> <li><a href="/fda-data-dashboard" target>Data Dashboard</a> (Inspections, Compliance Actions, Recalls, and Imports)</li> <li><a href="https://support.dnb.com/?cust=ImportSafetyRegistration/">UFI (DUNS): Import Safety Lookup Portal (dnb.com)</a></li> <li><a href="http://wayback.archive-it.org/7993/20171114142634/https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm270851.htm" target="_blank">Product Tracing</a> [ARCHIVED]</li> <li><a href="/food/food-safety-modernization-act-fsma/compliance-dates" target>Key FSMA Compliance Dates</a>             </li> <li><a a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ee6fda8c-9721-4886-bdc1-6270753f267c" href="/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/milk-guidance-documents-regulatory-information" target title="Milk Guidance Documents & Regulatory Information">Pasteurized Milk Ordinance</a></li> <li><a href="https://datadashboard.fda.gov/ora/fd/fser.htm" target="_blank">Supplier Evaluation Resources</a> <ul> <li><a href="/food/food-safety-modernization-act-fsma/industry-resources-third-party-audit-standards-and-fsma-supplier-verification-requirements" target>Industry Resources on Third-Party Audit Standards and FSMA Supplier Verification Requirements</a></li> <li><a href="/food/importing-food-products-united-states/accredited-third-party-certification-program-voluntary-audit-templates" target>Accredited Third-Party Certification Program Voluntary Audit Templates</a></li> </ul> </li> </ul> <p><em>Additional tools and resources for industry listed on the rule and program pages above. </em></p> </div> </div> </div> <div title="FSMA Background" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f4f4"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f4f4" aria-controls="67469e228f4f4">FSMA Background</a> </h2> </div> <div id="67469e228f4f4" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f4f4"> <div class="panel-body">   <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8ba9f100-bbc5-4ada-a0b3-e3a552e445d5" href="/food/food-safety-modernization-act-fsma/whats-new-fsma" title="What's New in FSMA">What's New in FSMA</a></li> <li><a href="/food/food-safety-modernization-act-fsma/reports-studies" target>Reports & Studies</a></li> <li><a href="/food/food-safety-modernization-act-fsma/operational-strategy-implementing-fda-food-safety-modernization-act-fsma" target>Operational Strategy for Implementing FSMA</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4cd33a10-915a-4937-b46f-c181b78e14c4" href="/food/food-safety-modernization-act-fsma/background-fda-food-safety-modernization-act-fsma" title="Background on the FDA Food Safety Modernization Act (FSMA)">Background on FSMA</a></li> </ul> </div> </div> </div> <div title="FSMA's Impact on Public Health" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67469e228f585"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67469e228f585" aria-controls="67469e228f585">FSMA's Impact on Public Health</a> </h2> </div> <div id="67469e228f585" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67469e228f585"> <div class="panel-body">   <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="16183c90-d4d1-4865-bf71-1c45b5cb0ae7" href="/news-events/fda-voices/fda-food-safety-modernization-act-10-reflecting-our-progress-and-path-forward" title="The FDA Food Safety Modernization Act at 10: Reflecting on Our Progress and the Path Forward">The FDA Food Safety Modernization Act at 10: Reflecting on Our Progress and the Path Forward</a></li> <li><a href="/food/constituent-updates/fda-commissioner-addresses-state-agriculture-commissioners-announces-new-steps-enhance-collaboration" target>FDA Commissioner Addresses State Agriculture Commissioners: Announces New Steps to Enhance Collaboration with States and Ensure Farmers Are Prepared for FSMA</a></li> <li><a href="/food/food-safety-modernization-act-fsma/cfsans-senior-science-advisor-aims-build-bridges-advance-produce-safety" target>Q&A Conversation - Senior Science Advisor Aims to Build Bridges to Advance Produce Safety</a></li> <li><a href="/food/food-safety-modernization-act-fsma/what-do-importers-need-know-about-fsvp" target>Q&A Conversation - FSVP: What Do Importers Need to Know?</a></li> <li><a href="/food/food-safety-modernization-act-fsma/outlining-benefits-voluntary-qualified-importer-program" target>Q&A Conversation - Outlining the Benefits of the Voluntary Qualified Importer Program</a></li> <li><a href="/food/food-safety-modernization-act-fsma/protecting-food-supply-intentional-adulteration-such-acts-terrorism" target>Q&A Conversation - Protecting the Food Supply from Intentional Adulteration, such as Acts of Terrorism</a></li> <li><a href="/food/food-safety-modernization-act-fsma/taking-modern-integrated-approach-advancing-safety-imported-food" target>Q&A Conversation - Taking a Modern, Integrated Approach to Advancing the Safety of Imported Food</a></li> <li><a href="/food/food-safety-modernization-act-fsma/supporting-regulators-and-growers-across-country-produce-safety-network" target>Q&A Conversation - The Produce Safety Network: Supporting Regulators and Growers Across the Country</a></li> <li><a href="/food/food-safety-modernization-act-fsma/what-expect-now-larger-farms-must-comply-fsma-produce-safety-rule" target>Q&A Conversation - What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule</a></li> <li><a href="/food/food-safety-modernization-act-fsma/what-expect-next-compliance-dates-fsma-preventive-controls-animal-foods-rule" target>Q&A Conversation - What to Expect with the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule</a></li> </ul> </div> </div> </div> <div type="warning"> <div class="alert alert-warning"> <h2 class="text-align-center" style="margin-top: -5px;">Spotlight!</h2> <p class="text-align-center"><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="455b55d3-1279-475b-ab15-2a515cbe6040" href="/food/hfp-constituent-updates/fda-launches-fda-track-food-safety-dashboard-track-fsma-progress" title="FDA Launches the FDA-TRACK: Food Safety Dashboard to Track FSMA Progress">FDA Launches the FDA-TRACK: Food Safety Dashboard to Track FSMA Progress</a></p> </div> </div> </div> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-02-05T09:00:00Z">02/05/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Food & Beverages</li> </ul> <h2 class="lcds-description-list__item-heading">Law(s) & Regulation(s)</h2> <ul class="lcds-metadata-list"> <li role="menuitem">Food Safety Modernization Act</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">Food Safety Modernization Act (FSMA)</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-392bc8eb4f96c8dd99a9e62ed95e9d02999721636fed1bab6d076c60fe80a181"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma" class="lcds-section-nav__link lcds-section-nav--side__link">Frequently Asked Questions on FSMA</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry" class="lcds-section-nav__link lcds-section-nav--side__link">FSMA Rules & Guidance for Industry</a></li> <li><a href="/food/food-safety-modernization-act-fsma/whats-new-fsma" class="lcds-section-nav__link lcds-section-nav--side__link">What's New in FSMA</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-training" class="lcds-section-nav__link lcds-section-nav--side__link">FSMA Training</a></li> <li><a href="/food/food-safety-modernization-act-fsma/fsma-technical-assistance-network-tan" class="lcds-section-nav__link lcds-section-nav--side__link">FSMA Technical Assistance Network (TAN)</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-3940a90c4f323731f412a782d269c47281e6a1d000e2362412e7c15c2903e701"> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <section class="lcds-subscribe" id="subscribe"> <div class="row"> <div class="col-sm-12 col-md-3 col-md-offset-3"> <h2>SUBSCRIBE</h2> <p>Get regular FDA email updates delivered on this topic to your inbox.</p> </div> <div class="col-sm-12 col-md-3"> <form class="form-horizontal" id="GD-snippet-form" 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