Hazard analysis and risk-based preventive controls or HARPC is a successor to the

Hazard analysis and critical control points Hazard analysis and critical control points, or HACCP (), is a systematic preventive approach to food safety from biological hazard, biological, chemical hazard, chemical, and physical hazards in production processes that can cause the finished ...

(HACCP) food safety system, mandated in the

United States The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...

by the

FDA Food Safety Modernization Act The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. Th ...

(FSMA) of 2010. Preventive control systems emphasize prevention of risks before they occur rather than their detection after they occur. The

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

released the rules in the

Federal Register The ''Federal Register'' (FR or sometimes Fed. Reg.) is the government gazette, official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices. It is published every wee ...

from September 2015 onwards. The first release of rules addressed Preventive Controls for Human Food and Preventive Controls for Foods for Animals. 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. The Sanitary Transportation of Human and Animal Food final rule was issued on April 6, 2016, and the Mitigation Strategies To Protect Food Against Intentional Adulteration (Food Defense) final rule was issued on May 27, 2016.

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 Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA) was signed by the President, the Department of Health and Human Services ( DHHS) and the U.S. Department of Agriculture ...

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 () and Seafood HACCP () 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. Additionally, for the first time food safety is being extended to

pet food Pet food is animal feed intended for consumption by pets. Typically sold in pet stores and supermarkets, it is usually specific to the type of animal, such as dog food or cat food. Most meat used for animals is a byproduct of the human food indus ...

and

animal feed Animal feed is food given to domestic animals, especially livestock, in the course of animal husbandry. There are two basic types: fodder and forage. Used alone, the word ''feed'' more often refers to fodder. Animal feed is an important input ...

, with firms being given an extra year to implement

Current Good Manufacturing Practices Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of Food industry, food and Drink industry, beve ...

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 CGMP is an initialism. It can refer to: *cyclic guanosine monophosphate (cGMP) * current good manufacturing practice (cGMP) *CGMP, Cisco Group Management Protocol, the Cisco version of Internet Group Management Protocol The Internet Group Manag ...

, 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. 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 Whole genome sequencing (WGS), also known as full genome sequencing or just genome sequencing, is the process of determining the entirety of the DNA sequence of an organism's genome at a single time. This entails sequencing all of an organism's ...

to match the exact strain of pathogen isolated from hospital patients to DNA recovered from food manufacturing facilities. * FSMA requires that a "Preventive Controls Qualified Individual" (PCQI) with training and experience oversee the plan. 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. * FSMA-compliant Food Safety Plans rely on Prerequisite Programs such as GMPs, allergen controls,

Integrated Pest Management Integrated pest management (IPM), also known as integrated pest control (IPC) integrates both chemical and non-chemical practices for economic control of pests. The UN's Food and Agriculture Organization defines IPM as "the careful consideratio ...

and vetting suppliers far more than HACCP plans, since these programs tend to be preventive. * FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems. * FSMA explicitly requires a Food Defense component, with both

terrorism Terrorism, in its broadest sense, is the use of violence against non-combatants to achieve political or ideological aims. The term is used in this regard primarily to refer to intentional violence during peacetime or in the context of war aga ...

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. * FSMA-compliant Food Safety Plans allow Corrections in place of Corrective Actions when the public health is not threatened. 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 Discovery may refer to: * Discovery (observation), observing or finding something unknown * Discovery (fiction), a character's learning something unknown * Discovery (law), a process in courts of law relating to evidence Discovery, The Discovery ...

during investigations or lawsuits. * FSMA-compliant Food Safety Plans are to be reviewed once every three years, as opposed to yearly with HACCP.

References

External links

Food Safety Preventive Controls Alliance's ''Preventive Controls for Human Food''
{{DEFAULTSORT:Hazard Analysis and risk-based preventive controls Food safety Food technology Quality management Hazard analysis United States Department of Agriculture

Scope

Differences between FSMA Preventive Controls and HACCP

See also

References

External links