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HACCP Principles: Benchmark for Food Safety
The HACCP food safety system has become a globally recognized standard
by Robert A. Savage and Daniel Lafontaine, PhD
The hazard analysis and critical control points (HACCP) food safety system was developed by the Pillsbury Company, the National Aeronautics and Space Administration, and the U.S. Army Natick Laboratories in the late 1960s to develop foods for the space program.
First presented by Pillsbury at the 1971 National Conference on Food Protection, the HACCP system initially consisted of procedures designed for three purposes:
- • identification and assessment of hazards associated with the growing, harvesting, processing-manufacturing, marketing, preparation, and use of a given raw material or food product;
- • determination of critical control points (CCPs) at which identified hazards could be controlled; and
- • establishment of procedures to monitor the CCPs.
These procedures were used, in part, by the low-acid canned food (LACF) industry in the development of good manufacturing practices to address Clostridium botulinum concerns in the early 1970s and, in 1973, by the U.S. Food and Drug Administration (FDA) to promulgate LACF regulations, which are contained in 21 Code of Federal Regulations (CFR) Part 113.
HACCP has gained international status as the premier food safety system in the European Union, Canada, Australia, and New Zealand, as well as other countries, and it serves as the foundation of the World Health Organization’s Codex Alimentarius Commission’s General Principles of Food Hygiene.
In 1980, at the request of the FDA, the U.S. Department of Agriculture (USDA), the National Marine Fisheries Service, and the Natick Research and Development Center, the National Research Council (NRC) convened a panel of experts to formulate general principles for the application of microbiological criteria for foods. Based on the panel’s review, the HACCP principles introduced at the 1971 National Conference on Food Protection were endorsed, along with the recommendation that the principles be made mandatory for all food processors.
The NRC also recommended formation of a commission on microbiological criteria for foods, which was subsequently established in 1988 as the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), to advise food regulatory agencies about food safety. NACMCF drafted a guide containing HACCP principles and published papers in 1989, 1992, and 1997 that articulated and expanded the original HACCP principles. The principles, as defined in the NACMCF’s Hazard Analysis and Critical Control Points Principles and Application Guidelines, published in 1997, are the benchmark for all food safety programs (see Table 1).
The FDA promulgated HACCP regulations (21 CFR Parts 123 and 1240) in 1995. These mandated HACCP for all seafood production in the United States, as well as any seafood exported to the United States. This was followed in 1996 by a mandate from the USDA’s Food Safety and Inspection Service for all federal- and state-inspected meat and poultry establishments, as well as for those establishments exporting meat and poultry to the United States, to follow HACCP guidelines (9 CFR 417). In 2001, the FDA again used HACCP, addressing serious public health issues associated with unpasteurized juice drinks by mandating HACCP (21 CFR 120) in the domestic juice industry, as well as for any companies that export juice to the United States.
HACCP has also gained international status as the premier food safety system in the European Union, Canada, Australia, and New Zealand, as well as other countries, and it serves as the foundation of the World Health Organization’s Codex Alimentarius Commission’s General Principles of Food Hygiene.
For decades, the food industry has voluntarily embraced the HACCP principles as a system for improving food safety and conducting business. Many in the food service, dairy processing, produce, and live animal production industry have developed and implemented HACCP-based systems or good manufacturing practices consistent with the principles articulated by the NACMCF.
Given the continued focus on the safety of our food supply, and considering recent food safety scares, a group of international retailers identified the need to enhance food safety and to ensure and strengthen customer and consumer protection. In 2000, they launched the Global Food Safety Initiative (GFSI), which sets requirements for food safety schemes through a benchmarking process to improve cost efficiency throughout the food supply chain. GFSI benchmarks existing food standards against food safety criteria and develops mechanisms for information exchange in the supply chain, consumer awareness, and review of existing good retail practices.
Through benchmarking, food safety-related schemes are compared to the GFSI Guidance Document, available at www.globalfoodsafetyinitiative.com. As a result of this process, GFSI has recognized several schemes that provide consistent results related to common requirements applied during the audit process. To date, GFSI fully recognizes five manufacturing schemes (see Table 2). Each scheme is based on the food safety standards articulated by the Codex Alimentarius Commission. Two schemes, the British Retail Consortium (BRC) and Safe Quality Foods (SQF), are gaining wide acceptance by U.S. processors, helping them to improve food safety and to retain their positions as suppliers to large retailers such as Wal-Mart.
Despite all the gains HACCP has made over the past several decades, more work is needed. Following recent foodborne illness outbreaks associated with peanut butter, chili peppers, spinach, lettuce, and other foods, the U.S. Congress is taking action to strengthen the FDA’s food safety responsibilities.
On July 30, 2009, the U.S. House of Representatives passed H.R. 2749, the Food Safety Enhancement Act of 2009. In Section 102, titled Hazard Analysis, Risk-Based Preventive Controls, Food Safety Plan, Finished Product Test Results from Category 1 Facilities, the act requires the Health and Human Services Secretary to “…issue guidance or promulgate regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, identifying and implementing preventive controls, and documenting the implementation of the preventive controls, including verification and corrective actions under sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)).”
Additional language is contained within H.R. 2749 that requires owners, operators, or agents of a facility to conduct a hazard analysis; identify, implement, and validate effective preventive measures; monitor preventive controls; institute corrective actions when monitoring shows that preventive controls have not been properly implemented or were ineffective; conduct verification activities; maintain records of monitoring, corrective action, and verification; and reanalyze for hazards. It also requires that owners, operators, or agents in charge of a facility develop and implement a written food safety plan before a facility introduces, or delivers for introduction, any shipment of food into commerce.
Section 5 of H.R. 2749 specifically exempts products regulated by the Secretary of Agriculture under the Federal Meat Inspection Act (FMIA)(21 U.S.C. 601 et seq.); the Poultry Products Inspection Act (PPIA)(21 U.S.C. 451 et seq.); or the Egg Products Inspection Act (EPIA)(21 U.S.C. 1031 et seq.). Additionally, it exempts livestock and poultry, USDA-regulated facilities, and farms to the extent that such farms raise animals from which food is derived that is regulated under FMIA, PPIA or EPIA.
The effective date in the act is 18 months after its enactment; implementation by small facilities is two years after enactment, and for very small facilities, three years.
In November 2009, the U.S. Senate Committee on Health, Education, Labor and Pensions approved S. 510, the FDA Food Safety Modernization Act, which changes the way FDA handles food supply safety. According to S. 510, “Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services … shall promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).”
Section 418, Hazard Analysis and Risk-Based Preventive Controls, states: “The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurance that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.” Here, a facility is defined as “… a domestic facility or a foreign facility that is required to register under section 415.”
The FDA Food Safety Modernization Act considers exempt from the provisions of the act those facilities in compliance with the FDA Seafood Hazard Analysis Control Points Program, the Juice Hazard Analysis Critical Control Point Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards—or any successor standards. Further, the Health and Human Services Secretary may, by regulation, exempt or modify the compliance requirements for facilities solely engaged in production of animal food, storage of agricultural commodities for distribution or processing, or storage of packaged foods not exposed to the environment. Nothing in the act will apply to either dietary supplements or alcohol-related facilities.
The two bills will probably be reconciled in committee for final approval by Congress in early 2010. With the passage of this landmark legislation, added to decades of efforts by the food industry and regulatory bodies to develop, implement, and maintain food safety programs based on HACCP principles, the U.S. food supply will remain one of the safest in the world. ■