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

Revision as of 01:41, 15 March 2023

Revision as of 20:25, 29 March 2023

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*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’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-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.