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}}