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Steveprutz (talk | contribs) Adding short description: "Food safety regulations" (Shortdesc helper) |
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==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 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 |access-date=2 May 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 include 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 |access-date=2 May 2016 }} </ref>
*FSMA-compliant 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 |access-date= 4 May 2016}}</ref><ref>{{cite news |last=Surak |first=John G. |issue=
*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 |access-date=2 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 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, as opposed to yearly with HACCP.
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