Hazard analysis and risk-based preventive controls

Food safety

Terms
Foodborne illness
Hazard analysis and critical control points (HACCP)  • Hazard analysis and risk-based preventive controls (HARPC)
Critical control point
Critical factors
FAT TOM
pH
Water activity (aw)
Bacterial pathogens
Clostridium botulinum
Escherichia coli
Listeria
Salmonella
Vibrio cholerae
Viral pathogens
Enterovirus
Hepatitis A
Norovirus
Rotavirus
Parasitic pathogens
Cryptosporidium
Entamoeba histolytica
Giardia
Trichinella

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.^[1] The FDA is releasing the rules in the Federal Registry beginning in September 2015.^[2] The first release of rules addressed Preventive Controls for Human Food and Preventive Controls for Foods for Animals.^[3] 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.^[4] The Sanitary Transportation of Human and Animal Food final rule was issued on April 6, 2016,^[5] and the Mitigation Strategies To Protect Food Against Intentional Adulteration (Food Defense) final rule was issued on May 27, 2016.^[6]

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 (21 C.F.R. 120) and Seafood HACCP (21 C.F.R. 123) are exempt.
• 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.^[7]

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 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.^[8]

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.^[9]
• FSMA requires that a "Preventive Controls Qualified Individual" (PCQI) with training and experience oversee the plan.^[10] 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 includes their own supplier vetting program.^[11][12]
• 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.^[13][14]
• FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems.^[15]
• 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 Preventative Controls. Preventive Controls do not require specific Critical Limits.^[16]
• FSMA-compliant Food Safety Plans allow Corrections in place of Corrective Actions when the public health is not threatened.^[17] 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 during investigations or lawsuits.
• FSMA-compliant Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.

See also

• Failure mode and effects analysis
• Failure mode, effects, and criticality analysis
• Fault tree analysis
• Food defense
• Food safety
• Design Review Based on Failure Mode
• Fast food restaurant
• ISO 22000
• Hazard analysis
• Hazop
• Hygiene
• Sanitation
• Sanitation Standard Operating Procedures
• Codex Alimentarius
• Total quality management

References

1. Sherod, Anne (11 May 2015). "The ABCs Of Building A Food Safety Plan: From HACCP To HARPC". foodonline.com. Retrieved 2 May 2016.
2. Bonar, Samantha (10 September 2015). "FDA takes important steps in modernizing food safety system". Los Angeles Times. Retrieved 10 September 2015.
3. Horsfall, Scott. "First FSMA Rules Finalized by FDA". LGMA. Retrieved 17 September 2015.
4. "FDA Issues Final Rules on Produce Safety, Imported Foods". Food Quality & Safety. 16 November 2015. Retrieved 20 November 2015.
5. 81 FR 20091
6. Whitworth, Joe (27 May 2016). "FDA issues rule to protect against intentional adulteration". Food Quality News. Retrieved 1 June 2016.
7. "FSMA Final Rule for Preventive Controls for Human Food". fda.gov. Food and Drug Administration. 22 October 2015. Retrieved 24 October 2015.
8. "FSMA Final Rule for Preventive Controls for Animal Food". fda.gov. Food and Drug Administration. 21 October 2015. Retrieved 24 October 2015.
9. Alonso-Zaldiva, Ricardo (9 June 2016). "Investigator: FDA still taking months to recall tainted food". Bradenton Herald. Bradenton, Florida. Retrieved 9 June 2016.
10. Viswanathan, Sangita (13 March 2015). "What to do Now to Migrate from HACCP to HARPC". foodsafetytech.com. Retrieved 2 May 2016.
11. Hermida, Maile Gradison (April–May 2016). "Ten Considerations for Developing a FSMA-Compliant Supplier Verification Program". Food Safety Magazine. Retrieved 8 September 2016.
12. Gallegos, Antonio (10 February 2016). "Prevention Instead of Correction: FDA Implements New System for Food Safety Regulation". naturalproductsinsider.com. Retrieved 2 May 2016.
13. Yotty, Amanda M.; Marcy, John A.; Pohlman, Fred W.; Edgar, Leslie D. "How Food Companies Can Modify Their Existing HACCP Plans into an All-Encompassing Food Safety Plan". Food Safety Magazine (December 2015/January 2016). Retrieved 4 May 2016.
14. Surak, John G. "PROCESS CONTROL: A New Paradigm for Validation, Verification and Monitoring". Food Safety Magazine (August/September 2014). Retrieved 6 May 2016.
15. Lindstrom, Eric (13 March 2013). "Do you know your HACCP from your HARPC?". Food Processing. Retrieved 2 May 2016.
16. Davis, Steve (April 2014). "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" (PDF). retailfoodalliance.com. Wholesale & Retail Food Alliance. Retrieved 2 May 2016. 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.
17. King, Hal; Ades, Gary. "Hazard Analysis and Risk-Based Preventive Controls (HARPC): The New GMP for Food Manufacturing". Food Safety Magazine (October/November 2015). Retrieved 2 May 2016.

External links

• Food Safety Preventive Controls Alliance's Preventive Controls for Human Food