Hazard analysis and risk-based preventive controls
 | |
| 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 of 2010. Exact details of the differences between HARPC and HACCP are in flux, as the FDA is releasing the rules in the Federal Registry beginning in September 2015 and continuing until 2018.[1] The first release of rules addressed Preventive Controls for Human Food and Preventive Controls for Foods for Animals.[2] 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.[3]
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 HARPC 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 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.[4]
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 HARPC 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.[5]
The FDA estimates that 73,000 businesses currently fall under these definitions.
See also
- Failure mode and effects analysis
- Failure mode, effects, and criticality analysis
- Fault tree analysis
- 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
- ↑ Bonar, Samantha (10 September 2015). "FDA takes important steps in modernizing food safety system". Los Angeles Times. Retrieved 10 September 2015.
- ↑ Horsfall, Scott. "First FSMA Rules Finalized by FDA". LGMA. Retrieved 17 September 2015.
- ↑ "FDA Issues Final Rules on Produce Safety, Imported Foods". Food Quality & Safety. 16 November 2015. Retrieved 20 November 2015.
- ↑ "FSMA Final Rule for Preventive Controls for Human Food". fda.gov. Food and Drug Administration. 22 October 2015. Retrieved 24 October 2015.
- ↑ "FSMA Final Rule for Preventive Controls for Animal Food". fda.gov. Food and Drug Administration. 21 October 2015. Retrieved 24 October 2015.