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

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{{Short description|Food safety regulations}}

{{Food safety}}

'''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.

'''Hazard analysis and risk-based preventive controls''' or '''HARPC''' is a successor to the [[Hazard analysis and critical control points]] (HACCP) food safety system. It is mandated by the [[FDA Food Safety Modernization Act]] (FSMA) of 2010. As the name implies, Preventive Controls systems emphasize prevention of hazards 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}}</ref> The [[FDA]] is releasing the rules in the Federal Registry beginning in September 2015.<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 |___location= |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 |date= |website= |publisher=LGMA |access-date=17 September 2015}}</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 |___location= |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 |___location= |access-date=1 June 2016}}</ref>

'''Hazard analysis and risk-based preventive controls''' or '''HARPC''' is a successor to the [[Hazard analysis and criticalPreventive control points]] (HACCP) food safety system. It is mandated by the [[FDA Food Safety Modernization Act]] (FSMA) of 2010. As the name implies, Preventive Controls 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]] is releasingreleased the rules in the [[Federal RegistryRegister]] beginning infrom 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 |___location= |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 |datepublisher=LGMA |websiteaccess-date=17 September 2015 |publisherarchive-url=LGMAhttps://web.archive.org/web/20151011053044/http://www.lgma.ca.gov/2015/09/first-fsma-rules-finalized-by-fda/ |accessarchive-date=1711 SeptemberOctober 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 |___location= |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 |___location= |access-date=1 June 2016}}</ref>

==Scope==

All food companies in the United States that are required to register with the FDA under the [[Public Health Security and Bioterrorism Preparedness and Response Act]] 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:

* 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.

* Businesses subject to Juice HACCP ({{CodeFedReg|21|120}}) and Seafood HACCP ({{CodeFedReg|21|123}}) are exempt.

*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.

* Businesses subject to Juice HACCP ({{CodeFedReg | 21 | 120}}) and Seafood HACCP ({{CodeFedRegthe |[[Pasteurized 21Milk |Ordinance]]; 123}})Sept are17, exempt2018.

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

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

* All other businesses; Sept 17, 2016.<ref>{{cite web |url=httphttps://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 |quote=}}</ref>

*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=http://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm#Compliance_Dates |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 |quote=}}</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:

* 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.

* 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 |quote=}}</ref>

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

*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.

*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=http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates |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 |quote=}}</ref>

The FDA estimates that 73,000 businesses currently fall under these definitions.

==Differences between FSMA Preventive Controls and HACCP==

* FSMA places a much stronger emphasis on science, research and prior experience with outbreaks than HACCP. For example, the FDA now uses [[whole genome sequencing]] to match the exact strain of pathogen isolated from hospital patients to DNA recovered from food manufacturing facilities.<ref>{{cite news |last=Alonso-Zaldiva |first=Ricardo |date=9 June 2016 |title=Investigator: FDA still taking months to recall tainted food |url=http://www.bradenton.com/news/business/article82698737.html |newspaper=Bradenton Herald |___location=Bradenton, Florida |access-date=9 June 2016 }}{{dead link|date=October 2017 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{cite news |author=<!--Staff writer(s); no by-line.--> |title=How Whole-Genome Sequencing Can Help Fight Foodborne Illness |url=https://www.foodsafetymagazine.com/news/how-whole-genome-sequencing-can-help-fight-foodborne-illness |date=14 September 2017 |access-date=18 September 2017 |archive-date=24 January 2019 |archive-url=https://web.archive.org/web/20190124203529/https://www.foodsafetymagazine.com/news/how-whole-genome-sequencing-can-help-fight-foodborne-illness/ |url-status=dead }}</ref>

* FSMA placesrequires that a much"Preventive strongerControls emphasisQualified onIndividual" science,(PCQI) with researchtraining and prior experience with outbreaks than HACCP. For example,oversee the FDA now uses [[whole genome sequencing]] to match the exact strain of pathogen isolated from hospital patients to DNA recovered from food manufacturing facilitiesplan.<ref>{{cite news |last=Alonso-ZaldivaViswanathan |first=RicardoSangita |date=913 JuneMarch 20162015 |title=Investigator:What FDAto stilldo taking monthsNow to recallMigrate taintedfrom foodHACCP to HARPC |url=httphttps://www.bradentonfoodsafetytech.com/newsfeature_article/business/article82698737.htmlwhat-to-do-now-to-migrate-from-haccp-to-harpc |newspaper=Bradenton Herald |___location=Bradenton, Floridafoodsafetytech.com |access-date=92 JuneMay 2016}}</ref> HACCP assigned responsibilities to a team drawn from management.

* 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 includesinclude their own supplier vetting program.<ref>{{cite news |last=Hermida |first=Maile Gradison |date=April–May 2016 |title=Ten Considerations for Developing a FSMA-Compliant Supplier Verification Program |url=http://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2016/ten-considerations-for-developing-a-fsma-compliant-supplier-verification-program |newspaper=Food Safety Magazine |access-date=8 September 2016 |archive-date=7 September 2016 |archive-url=https://web.archive.org/web/20160907110115/http://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2016/ten-considerations-for-developing-a-fsma-compliant-supplier-verification-program/ |url-status=dead }}</ref><ref>{{cite web |url=http://www.naturalproductsinsider.com/articles/2016/02/prevention-instead-of-correction-fda-implements-n.aspx |title=Prevention Instead of Correction: FDA Implements New System for Food Safety Regulation |last1=Gallegos |first1=Antonio |date=10 February 2016 |website=naturalproductsinsider.com |publisher= |access-date=2 May 2016 |quote=}} </ref>

*FSMA requires that a "Preventive Controls Qualified Individual" (PCQI) with training and experience oversee the plan.<ref>{{cite news |last=Viswanathan |first=Sangita |date=13 March 2015 |title=What to do Now to Migrate from HACCP to HARPC |url=https://foodsafetytech.com/feature_article/what-to-do-now-to-migrate-from-haccp-to-harpc |newspaper=foodsafetytech.com |___location= |access-date=2 May 2016}}</ref> HACCP assigned responsibilities to a team drawn from management.

* FSMA-complaintcompliant Food Safety Plans rely on Prerequisite Programs such as GMPs, allergen controls, [[Integrated Pest Management]] and vetting suppliers far more than HACCP plans, since these programs tend to be preventive.<ref>{{cite news |last1=Yotty |first1=Amanda M. |last2=Marcy |first2=John A. |last3=Pohlman |first3=Fred W. |last4=Edgar |first4=Leslie D. |issue=December 2015/January 2016 |title=How Food Companies Can Modify Their Existing HACCP Plans into an All-Encompassing Food Safety Plan |url=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/ |newspaper=Food Safety Magazine |___location= |access-date= 4 May 2016}}</ref><ref>{{cite news |last=Surak |first=John G. |issue= August/September 2014 |title=PROCESS CONTROL: A New Paradigm for Validation, Verification and Monitoring |url=http://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring |newspaper=Food Safety Magazine |___location= |access-date=6 May 2016 |archive-date=25 January 2019 |archive-url=https://web.archive.org/web/20190125130906/https://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring/ |url-status=dead }}</ref>

*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 includes their own supplier vetting program.<ref>{{cite web |url=http://www.naturalproductsinsider.com/articles/2016/02/prevention-instead-of-correction-fda-implements-n.aspx |title=Prevention Instead of Correction: FDA Implements New System for Food Safety Regulation |last1=Gallegos |first1=Antonio |date=10 February 2016 |website=naturalproductsinsider.com |publisher= |access-date=2 May 2016 |quote=}} </ref>

* FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems.<ref>{{cite news |last=Lindstrom |first=Eric |date=13 March 2013 |title=Do you know your HACCP from your HARPC? |url=http://www.foodprocessing.com/articles/2013/fda-haccp-harpc |newspaper=Food Processing |___location= |access-date=2 May 2016}}</ref>

*FSMA-complaint Food Safety Plans rely on Prerequisite Programs such as GMPs, allergen controls, [[Integrated Pest Management]] and vetting suppliers far more than HACCP plans, since these programs tend to be preventive.<ref>{{cite news |last1=Yotty |first1=Amanda M. |last2=Marcy |first2=John A. |last3=Pohlman |first3=Fred W. |last4=Edgar |first4=Leslie D. |issue=December 2015/January 2016 |title=How Food Companies Can Modify Their Existing HACCP Plans into an All-Encompassing Food Safety Plan |url=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/ |newspaper=Food Safety Magazine |___location= |access-date= 4 May 2016}}</ref><ref>{{cite news |last=Surak |first=John G. |issue= August/September 2014 |title=PROCESS CONTROL: A New Paradigm for Validation, Verification and Monitoring |url=http://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/a-new-paradigm-for-validation-verification-and-monitoring |newspaper=Food Safety Magazine |___location= |access-date=6 May 2016 }}</ref>

* FSMA explicitly requires a [[Food Defense]] component, with both [[terrorism]] and [[Economically Motivated Adulteration]] addressed. Businesses with less than $10,000,000 a year in sales are exempt.

*FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems.<ref>{{cite news |last=Lindstrom |first=Eric |date=13 March 2013 |title=Do you know your HACCP from your HARPC? |url=http://www.foodprocessing.com/articles/2013/fda-haccp-harpc |newspaper=Food Processing |___location= |access-date=2 May 2016}}</ref>

* FSMA-complaintcompliant Food Safety Plans de-emphasize Critical Control Points in favor of PreventativePreventive Controls. Preventive Controls do not require specific Critical Limits.<ref>{{cite web |url=http://retailfoodalliance.com/html/HACCP%20vs%20HARPC.pdf |title=The FDA’sFDA'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 explicitly requires a [[Food Defense]] component, with both [[terrorism]] and [[Economically Motivated Adulteration]] addressed. Businesses with less than $10,000,000 a year in sales are exempt.

* FSMA-complaintcompliant 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 |___location= |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-complaint Food Safety Plans de-emphasize Critical Control Points in favor of Preventative 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.}}</ref>

* FSMA-complaintcompliant Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.

*FSMA-complaint 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 |___location= |access-date=2 May 2016}}</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-complaint Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.

==See also==

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==External links==

* [http://www.iit.edu/ifsh/alliance/pdfs/FSPCA_PC_Human_Food_Course_Participant_Manual_V1.2_Watermark.pdf Food Safety Preventive Controls Alliance's ''Preventive Controls for Human Food'']

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{{DEFAULTSORT:Hazard Analysis and risk-based preventive controls}}

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