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

Revision as of 21:04, 19 July 2016

Revision as of 21:40, 2 August 2016

Line 1:

{{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. It is mandated by the [[FDA Food Safety Modernization Act]] (FSMA) of 2010. As the name implies, HARPCPreventive 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>

==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 HARPCFSMA-compliant planFood 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.

Line 11:

*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 HARPCPreventive 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.

Line 20:

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

==Differences between HARPCFSMA Preventive Controls and HACCP==

*HARPCFSMA 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}}</ref>

*HARPCFSMA plans requirerequires 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.

*HARPCFSMA 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, and HARPC 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>

*HARPCFSMA-complaint plansFood 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>

*HARPCFSMA-compliant coversHazard 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>

*HARPCFSMA 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.

*HARPCFSMA-complaint Food Safety Plans de-emphasizesemphasize 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>

*HARPCFSMA-complaint allowsFood 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.

*HARPCFSMA-complaint plansFood Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.

==See also==