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Hazard analysis and risk-based preventive controls
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<h2 id="scope">Scope</h2> <p>All food companies in the United States that are required to register with the FDA under the <a href="/facts/Public_Health_Security_and_Bioterrorism_Preparedness_and_Response_Act/p4Ht9Akw">Public Health Security and Bioterrorism Preparedness and Response Act</a> of 2002, as well as firms outside the US that export food to the US, must have a written FSMA-compliant Food Safety Plan in place by the deadlines listed below: </p> <ul><li>Very small businesses of less than $1 million in sales per year are exempt, but must provide proof to the FDA of their very small status by January 1, 2016.</li> <li>Businesses subject to Juice HACCP (<a href="/facts/Title_21_of_the_Code_of_Federal_Regulations/D4a543oC">21 CFR</a> <a href="https://www.ecfr.gov/current/title-21/part-120">120</a>) and Seafood HACCP (<a href="/facts/Title_21_of_the_Code_of_Federal_Regulations/D4a543oC">21 CFR</a> <a href="https://www.ecfr.gov/current/title-21/part-123">123</a>) are exempt.</li> <li>Businesses subject to the Pasteurized Milk Ordinance; Sept 17, 2018.</li> <li>Small businesses, defined as having fewer than 500 full-time equivalent employees; Sept 17, 2017.</li> <li>All other businesses; Sept 17, 2016.<a class="footnote-ref" id="fnref:7" href="#fn:7"><sup>7</sup></a></li></ul> <p>Additionally, for the first time food safety is being extended to <a href="/facts/Pet_food/dGG3PEDY">pet food</a> and <a href="/facts/Animal_feed/3pYmdSFB">animal feed</a>, with firms being given an extra year to implement <a href="/facts/Current_Good_Manufacturing_Practices/s4sETf1y">Current Good Manufacturing Practices</a> before a Preventive Controls system the following year: </p> <ul><li>Primary Production Farms, defined as "an operation under one management in one general, but not necessarily contiguous, location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities" are exempt.</li> <li>Very small businesses of less than $2,500,000 in sales per year; Sept 17, 2018 for <a href="/facts/Good_manufacturing_practice/s4sETf1y">cGMP</a>, Sept 17, 2019 for Preventive Controls, but must provide proof of very small business status by January 1, 2017.</li> <li>Small businesses, having fewer than 500 full-time equivalent employees; Sept 17, 2017 for cGMP, Sept 17, 2018 for Preventive Controls.</li> <li>All other businesses; Sept 17, 2016 for cGMP, Sept 17, 2017 for Preventive Controls.<a class="footnote-ref" id="fnref:8" href="#fn:8"><sup>8</sup></a></li></ul> <p>The FDA estimates that 73,000 businesses currently fall under these definitions. </p> <h2 id="differences-between-fsma-preventive-controls-and-haccp">Differences between FSMA Preventive Controls and HACCP</h2> <ul><li>FSMA places a much stronger emphasis on science, research and prior experience with outbreaks than HACCP. For example, the FDA now uses <a href="/facts/Whole_genome_sequencing/WNuHaU2K">whole genome sequencing</a> to match the exact strain of pathogen isolated from hospital patients to DNA recovered from food manufacturing facilities.<a class="footnote-ref" id="fnref:9" href="#fn:9"><sup>9</sup></a><a class="footnote-ref" id="fnref:10" href="#fn:10"><sup>10</sup></a></li> <li>FSMA requires that a "Preventive Controls Qualified Individual" (PCQI) with training and experience oversee the plan.<a class="footnote-ref" id="fnref:11" href="#fn:11"><sup>11</sup></a> HACCP assigned responsibilities to a team drawn from management.</li> <li>FSMA requires that firms vet ("Verify") all their suppliers for the effectiveness of their food safety programs. This has the effect of drafting companies into the FSMA enforcement effort, since the Supplier Verification and Foreign Supplier Verification programs require that the suppliers provide written proof that they have Prerequisite Programs, and Preventive Controls systems which include their own supplier vetting program.<a class="footnote-ref" id="fnref:12" href="#fn:12"><sup>12</sup></a><a class="footnote-ref" id="fnref:13" href="#fn:13"><sup>13</sup></a></li> <li>FSMA-compliant Food Safety Plans rely on Prerequisite Programs such as GMPs, allergen controls, <a href="/facts/Integrated_Pest_Management/XWCwBShW">Integrated Pest Management</a> and vetting suppliers far more than HACCP plans, since these programs tend to be preventive.<a class="footnote-ref" id="fnref:14" href="#fn:14"><sup>14</sup></a><a class="footnote-ref" id="fnref:15" href="#fn:15"><sup>15</sup></a></li> <li>FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems.<a class="footnote-ref" id="fnref:16" href="#fn:16"><sup>16</sup></a></li> <li>FSMA explicitly requires a <a href="/facts/Food_Defense/ySUCnGkX">Food Defense</a> component, with both <a href="/facts/Terrorism/DHJGPJ6P">terrorism</a> and <a href="/facts/Economically_Motivated_Adulteration/ySUCnGkX">Economically Motivated Adulteration</a> addressed. Businesses with less than $10,000,000 a year in sales are exempt.</li> <li>FSMA-compliant Food Safety Plans de-emphasize Critical Control Points in favor of Preventive Controls. Preventive Controls do not require specific Critical Limits.<a class="footnote-ref" id="fnref:17" href="#fn:17"><sup>17</sup></a></li> <li>FSMA-compliant Food Safety Plans allow Corrections in place of Corrective Actions when the public health is not threatened.<a class="footnote-ref" id="fnref:18" href="#fn:18"><sup>18</sup></a> Corrections are not as strict regarding paperwork as Corrective Actions. The FDA believes that companies might have been avoiding making minor improvements because they felt that the paper trail of a Corrective Action would open them to legal risk due to <a href="/facts/Discovery_(law)/pHMb5suV">discovery</a> during investigations or lawsuits.</li> <li>FSMA-compliant Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.</li></ul> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/Failure_mode_and_effects_analysis/fdjxbXxP">Failure mode and effects analysis</a></li> <li><a href="/facts/Failure_mode%2c_effects%2c_and_criticality_analysis/Cx4RxoXo">Failure mode, effects, and criticality analysis</a></li> <li><a href="/facts/Fault_tree_analysis/rTD7Xd0t">Fault tree analysis</a></li> <li><a href="/facts/Food_defense/ySUCnGkX">Food defense</a></li> <li><a href="/facts/Food_safety/8lWIyLYE">Food safety</a></li> <li><a href="/facts/Design_Review_Based_on_Failure_Mode/j7S6RBpb">Design Review Based on Failure Mode</a></li> <li><a href="/facts/Fast_food_restaurant/Ib5RQzde">Fast food restaurant</a></li> <li><a href="/facts/ISO_22000/1kErhhSl">ISO 22000</a></li> <li><a href="/facts/Hazard_analysis/f3udTfLC">Hazard analysis</a></li> <li><a href="/facts/Hazop/xxmUV5aG">Hazop</a></li> <li><a href="/facts/Hygiene/zH17q0L0">Hygiene</a></li> <li><a href="/facts/Sanitation/NLGqBs2T">Sanitation</a></li> <li><a href="/facts/Sanitation_Standard_Operating_Procedures/PXhSAAxb">Sanitation Standard Operating Procedures</a></li> <li><a href="/facts/Codex_Alimentarius/tGogRU8m">Codex Alimentarius</a></li> <li><a href="/facts/Total_quality_management/JFSlCQ9B">Total quality management</a></li></ul> <h2 id="external-links">External links</h2> <ul><li><a href="http://www.iit.edu/ifsh/alliance/pdfs/FSPCA_PC_Human_Food_Course_Participant_Manual_V1.2_Watermark.pdf">Food Safety Preventive Controls Alliance's <i>Preventive Controls for Human Food</i></a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>Sherod, Anne (11 May 2015). "The ABCs Of Building A Food Safety Plan: From HACCP To HARPC". foodonline.com. Archived from the original on 14 December 2018. Retrieved 2 May 2016. <a href="https://web.archive.org/web/20181214114617/https://www.foodonline.com/doc/the-abc-s-of-building-a-food-safety-plan-from-haccp-to-harpc-0001" target="_blank">https://web.archive.org/web/20181214114617/https://www.foodonline.com/doc/the-abc-s-of-building-a-food-safety-plan-from-haccp-to-harpc-0001</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>Bonar, Samantha (10 September 2015). "FDA takes important steps in modernizing food safety system". Los Angeles Times. Retrieved 10 September 2015. <a href="http://www.latimes.com/food/dailydish/la-dd-fda-food-safety-system-20150910-story.html" target="_blank">http://www.latimes.com/food/dailydish/la-dd-fda-food-safety-system-20150910-story.html</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>Horsfall, Scott. "First FSMA Rules Finalized by FDA". LGMA. Archived from the original on 11 October 2015. Retrieved 17 September 2015. <a href="https://web.archive.org/web/20151011053044/http://www.lgma.ca.gov/2015/09/first-fsma-rules-finalized-by-fda/" target="_blank">https://web.archive.org/web/20151011053044/http://www.lgma.ca.gov/2015/09/first-fsma-rules-finalized-by-fda/</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>"FDA Issues Final Rules on Produce Safety, Imported Foods". Food Quality & Safety. 16 November 2015. Retrieved 20 November 2015. <a href="http://www.foodqualityandsafety.com/article/fda-issues-final-rules-on-produce-safety-imported-foods" target="_blank">http://www.foodqualityandsafety.com/article/fda-issues-final-rules-on-produce-safety-imported-foods</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>81 FR 20091 <a href="/wiki/Federal_Register" target="_blank">/wiki/Federal_Register</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>Whitworth, Joe (27 May 2016). "FDA issues rule to protect against intentional adulteration". Food Quality News. Retrieved 1 June 2016. <a href="http://www.foodqualitynews.com/Regulation-and-safety/FDA-finalises-last-FSMA-rule" target="_blank">http://www.foodqualitynews.com/Regulation-and-safety/FDA-finalises-last-FSMA-rule</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>"FSMA Final Rule for Preventive Controls for Human Food". fda.gov. Food and Drug Administration. 22 October 2015. Archived from the original on March 25, 2013. Retrieved 24 October 2015. <a href="https://web.archive.org/web/20130325011456/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates" target="_blank">https://web.archive.org/web/20130325011456/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> <li id="fn:8"><p>"FSMA Final Rule for Preventive Controls for Animal Food". fda.gov. Food and Drug Administration. 21 October 2015. Archived from the original on October 30, 2013. Retrieved 24 October 2015. <a href="https://web.archive.org/web/20131030025129/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates" target="_blank">https://web.archive.org/web/20131030025129/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates</a> <a href="#fnref:8" class="footnote-back-ref">↩</a></p></li> <li id="fn:9"><p>Alonso-Zaldiva, Ricardo (9 June 2016). "Investigator: FDA still taking months to recall tainted food". Bradenton Herald. Bradenton, Florida. Retrieved 9 June 2016.[permanent dead link] <a href="http://www.bradenton.com/news/business/article82698737.html" target="_blank">http://www.bradenton.com/news/business/article82698737.html</a> <a href="#fnref:9" class="footnote-back-ref">↩</a></p></li> <li id="fn:10"><p>"How Whole-Genome Sequencing Can Help Fight Foodborne Illness". 14 September 2017. Archived from the original on 24 January 2019. Retrieved 18 September 2017. <a href="https://web.archive.org/web/20190124203529/https://www.foodsafetymagazine.com/news/how-whole-genome-sequencing-can-help-fight-foodborne-illness/" target="_blank">https://web.archive.org/web/20190124203529/https://www.foodsafetymagazine.com/news/how-whole-genome-sequencing-can-help-fight-foodborne-illness/</a> <a href="#fnref:10" class="footnote-back-ref">↩</a></p></li> <li id="fn:11"><p>Viswanathan, Sangita (13 March 2015). "What to do Now to Migrate from HACCP to HARPC". foodsafetytech.com. Retrieved 2 May 2016. <a href="https://foodsafetytech.com/feature_article/what-to-do-now-to-migrate-from-haccp-to-harpc" target="_blank">https://foodsafetytech.com/feature_article/what-to-do-now-to-migrate-from-haccp-to-harpc</a> <a href="#fnref:11" class="footnote-back-ref">↩</a></p></li> <li id="fn:12"><p>Hermida, Maile Gradison (April–May 2016). "Ten Considerations for Developing a FSMA-Compliant Supplier Verification Program". Food Safety Magazine. Archived from the original on 7 September 2016. Retrieved 8 September 2016. <a href="https://web.archive.org/web/20160907110115/http://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2016/ten-considerations-for-developing-a-fsma-compliant-supplier-verification-program/" target="_blank">https://web.archive.org/web/20160907110115/http://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2016/ten-considerations-for-developing-a-fsma-compliant-supplier-verification-program/</a> <a href="#fnref:12" class="footnote-back-ref">↩</a></p></li> <li id="fn:13"><p>Gallegos, Antonio (10 February 2016). "Prevention Instead of Correction: FDA Implements New System for Food Safety Regulation". naturalproductsinsider.com. Retrieved 2 May 2016. <a href="http://www.naturalproductsinsider.com/articles/2016/02/prevention-instead-of-correction-fda-implements-n.aspx" target="_blank">http://www.naturalproductsinsider.com/articles/2016/02/prevention-instead-of-correction-fda-implements-n.aspx</a> <a href="#fnref:13" class="footnote-back-ref">↩</a></p></li> <li id="fn:14"><p>Yotty, Amanda M.; Marcy, John A.; Pohlman, Fred W.; Edgar, Leslie D. "How Food Companies Can Modify Their Existing HACCP Plans into an All-Encompassing Food Safety Plan". Food Safety Magazine. No. December 2015/January 2016. Retrieved 4 May 2016. <a href="http://www.foodsafetymagazine.com/magazine-archive1/december-2015january-2016/how-food-companies-can-modify-their-existing-haccp-plans-into-an-all-encompassing-food-safety-plan/" target="_blank">http://www.foodsafetymagazine.com/magazine-archive1/december-2015january-2016/how-food-companies-can-modify-their-existing-haccp-plans-into-an-all-encompassing-food-safety-plan/</a> <a href="#fnref:14" class="footnote-back-ref">↩</a></p></li> <li id="fn:15"><p>Surak, John G. "PROCESS CONTROL: A New Paradigm for Validation, Verification and Monitoring". Food Safety Magazine. No. August/September 2014. Archived from the original on 25 January 2019. Retrieved 6 May 2016. <a href="https://web.archive.org/web/20190125130906/https://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring/" target="_blank">https://web.archive.org/web/20190125130906/https://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring/</a> <a href="#fnref:15" class="footnote-back-ref">↩</a></p></li> <li id="fn:16"><p>Lindstrom, Eric (13 March 2013). "Do you know your HACCP from your HARPC?". Food Processing. Retrieved 2 May 2016. <a href="http://www.foodprocessing.com/articles/2013/fda-haccp-harpc" target="_blank">http://www.foodprocessing.com/articles/2013/fda-haccp-harpc</a> <a href="#fnref:16" class="footnote-back-ref">↩</a></p></li> <li id="fn:17"><p>Davis, Steve (April 2014). "The FDA's Food Safety Modernization Act (FSMA): Its requirements for Hazard Analysis and Risk-based Preventive Controls (HARPC) in the Proposed Preventive Controls Rule for Human Food" (PDF). retailfoodalliance.com. Wholesale & Retail Food Alliance. Archived from the original (PDF) on 21 October 2016. Retrieved 2 May 2016. Although this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls. <a href="https://web.archive.org/web/20161021204528/http://retailfoodalliance.com/html/HACCP%20vs%20HARPC.pdf" target="_blank">https://web.archive.org/web/20161021204528/http://retailfoodalliance.com/html/HACCP%20vs%20HARPC.pdf</a> <a href="#fnref:17" class="footnote-back-ref">↩</a></p></li> <li id="fn:18"><p>King, Hal; Ades, Gary. "Hazard Analysis and Risk-Based Preventive Controls (HARPC): The New GMP for Food Manufacturing". Food Safety Magazine. No. October/November 2015. Archived from the original on 25 January 2019. Retrieved 2 May 2016. <a href="https://web.archive.org/web/20190125073411/https://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/hazard-analysis-and-risk-based-preventive-controls-harpc-the-new-gmp-for-food-manufacturing/" target="_blank">https://web.archive.org/web/20190125073411/https://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/hazard-analysis-and-risk-based-preventive-controls-harpc-the-new-gmp-for-food-manufacturing/</a> <a href="#fnref:18" class="footnote-back-ref">↩</a></p></li> </ol>