Hazard analysis and risk-based preventive controls: Difference between revisions

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'''Hazard analysis and risk-based preventive controls''' or '''HARPC''' is a successor to the [[Hazard analysis and critical control points]] (HACCP) food safety system, mandated in the [[United States]] by the [[FDA Food Safety Modernization Act]] (FSMA) of 2010.

Preventive control systems emphasize prevention of hazardsrisks before they occur rather than their detection after they occur.<ref name="SherodABCs">{{cite web |last=Sherod |first=Anne |date=11 May 2015 |title=The ABCs Of Building A Food Safety Plan: From HACCP To HARPC |url=http://www.foodonline.com/doc/the-abc-s-of-building-a-food-safety-plan-from-haccp-to-harpc-0001 |website=foodonline.com |access-date=2 May 2016 |archive-url=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 |archive-date=14 December 2018 |url-status=dead }}</ref> The [[FDA]] released the rules in the [[Federal Register]] from September 2015 onwards.<ref>{{cite news |last=Bonar |first=Samantha |date=10 September 2015 |title=FDA takes important steps in modernizing food safety system |url=http://www.latimes.com/food/dailydish/la-dd-fda-food-safety-system-20150910-story.html |newspaper=Los Angeles Times |access-date= 10 September 2015 }}</ref> The first release of rules addressed Preventive Controls for Human Food and Preventive Controls for Foods for Animals.<ref>{{cite web |url=http://www.lgma.ca.gov/2015/09/first-fsma-rules-finalized-by-fda |title=First FSMA Rules Finalized by FDA |last1=Horsfall |first1=Scott |publisher=LGMA |access-date=17 September 2015 |archive-url=https://web.archive.org/web/20151011053044/http://www.lgma.ca.gov/2015/09/first-fsma-rules-finalized-by-fda/ |archive-date=11 October 2015 |url-status=dead }}</ref> The Produce Safety Final Rule, the Foreign Supplier Verification Programs (FSVP) Final Rule and the Accredited Third-Party Certification Final Rule were issued on November 13, 2015.<ref>{{cite news |author=<!--Staff writer(s); no by-line.--> |title=FDA Issues Final Rules on Produce Safety, Imported Foods |url=http://www.foodqualityandsafety.com/article/fda-issues-final-rules-on-produce-safety-imported-foods |newspaper=Food Quality & Safety |date=16 November 2015 |access-date=20 November 2015}}</ref> The Sanitary Transportation of Human and Animal Food final rule was issued on April 6, 2016,<ref>{{Federal Register|81|20091}}</ref> and the Mitigation Strategies To Protect Food Against Intentional Adulteration (Food Defense) final rule was issued on May 27, 2016.<ref>{{cite news |last=Whitworth |first=Joe |date=27 May 2016 |title=FDA issues rule to protect against intentional adulteration |url=http://www.foodqualitynews.com/Regulation-and-safety/FDA-finalises-last-FSMA-rule |newspaper=Food Quality News |access-date=1 June 2016}}</ref>

==Scope==

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* Businesses subject to the [[Pasteurized Milk Ordinance]]; Sept 17, 2018.

* Small businesses, defined as having fewer than 500 full-time equivalent employees; Sept 17, 2017.

* All other businesses; Sept 17, 2016.<ref>{{cite web |url=https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm#Compliance_Dates |archive-url=https://web.archive.org/web/20130325011456/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates |url-status=dead |archive-date=March 25, 2013 |title=FSMA Final Rule for Preventive Controls for Human Food |author=<!--Staff writer(s); no by-line.--> |date=22 October 2015 |website=fda.gov |publisher=Food and Drug Administration |access-date=24 October 2015 }}</ref>

Additionally, for the first time food safety is being extended to [[pet food]] and [[animal feed]], with firms being given an extra year to implement [[Current Good Manufacturing Practices]] before a Preventive Controls system the following year:

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* Very small businesses of less than $2,500,000 in sales per year; Sept 17, 2018 for [[Good manufacturing practice|cGMP]], Sept 17, 2019 for Preventive Controls, but must provide proof of very small business status by January 1, 2017.

* Small businesses, having fewer than 500 full-time equivalent employees; Sept 17, 2017 for cGMP, Sept 17, 2018 for Preventive Controls.

* All other businesses; Sept 17, 2016 for cGMP, Sept 17, 2017 for Preventive Controls.<ref>{{cite web |url=https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates |archive-url=https://web.archive.org/web/20131030025129/http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates |url-status=dead |archive-date=October 30, 2013 |title=FSMA Final Rule for Preventive Controls for Animal Food |author=<!--Staff writer(s); no by-line.--> |date=21 October 2015 |website=fda.gov |publisher=Food and Drug Administration |access-date=24 October 2015 }}</ref>

The FDA estimates that 73,000 businesses currently fall under these definitions. {{citation needed|date=March 2021}}

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* FSMA-compliant Food Safety Plans de-emphasize Critical Control Points in favor of Preventive Controls. Preventive Controls do not require specific Critical Limits.<ref>{{cite web |url=http://retailfoodalliance.com/html/HACCP%20vs%20HARPC.pdf |title=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 |last1=Davis |first1=Steve |date=April 2014 |website=retailfoodalliance.com |publisher=Wholesale & Retail Food Alliance |access-date=2 May 2016 |quote=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. |archive-date=21 October 2016 |archive-url=https://web.archive.org/web/20161021204528/http://retailfoodalliance.com/html/HACCP%20vs%20HARPC.pdf |url-status=dead }}</ref>

* FSMA-compliant Food Safety Plans allow Corrections in place of Corrective Actions when the public health is not threatened.<ref>{{cite news |last1=King |first1=Hal |last2=Ades |first2=Gary |issue=October/November 2015 |title=Hazard Analysis and Risk-Based Preventive Controls (HARPC): The New GMP for Food Manufacturing |url=http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/hazard-analysis-and-risk-based-preventive-controls-harpc-the-new-gmp-for-food-manufacturing |newspaper=Food Safety Magazine |access-date=2 May 2016 |archive-date=25 January 2019 |archive-url=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/ |url-status=dead }}</ref> 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 [[Discovery (law)|discovery]] during investigations or lawsuits.

* FSMA-compliant Food Safety Plans are to be reviewed once every three years<ref>{{Cite web |title=EnsureIQ.com - PCQI Quick Overview |url=https://www.ensureiq.com/blog/pcqi-quick-overview |access-date=2024-04-02 |website=www.ensureiq.com |language=en-US}}</ref>, as opposed to yearly with HACCP.

==See also==