Advanced HACCP systems have been mandated for decades AND can’t solve ag---they only resolve food safety hazards

In 2011, the U.S. Congress passed, and the president signed into law, the Food Safety Modernization Act (FSMA). A key regulation issued under the law is "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food". Among the requirements of the regulation is for food manufacturers to develop Hazard Analysis Risk-Based Preventive Control (HARPC) food safety plans. The underlying approach behind HARPC is close to that taken from globally accepted Hazard Analysis Critical Control Point (HACCP) principles. Both rely on experience and scientific data to proactively identify and evaluate process-specific food safety hazards and to develop appropriate, effective, and verifiable control measures. In this article, the evolution of the original HACCP principles towards HARPC is discussed and requirements within the FSMA regulation are summarized.

Background

Continuing efforts to prevent food from becoming contaminated during growing, processing, and distribution remains a high priority throughout the world. The World Health Organization (WHO) estimated that, in 2010, 600 million illnesses and 420,000 deaths occurred from consumption of contaminated food19. In the United States, the Centers for Disease Control and Prevention (CDC) estimates that approximately 48 million foodborne illnesses occur each year4. Many of these only cause minor symptoms that quickly pass. However, severe cases result in approximately 128,000 hospitalizations and 3000 deaths per year.

CDC surveillance data collected from U.S. State Departments of Health, hospital records, and death certificates show that less than half of reported illnesses are traced to known human microbial pathogens, such as norovirus, Salmonella spp., Campylobacter spp., Clostridium perfringens, pathogenic strains of E. coli, and Listeria monocytogenes19,22. More often, the microorganisms responsible for illness remains unknown23. Most cases of foodborne illness are related to food handling and preparation practices in restaurants and home kitchens1,4. However, highly publicized multistate outbreaks have been linked to contamination that occurred on farms, in packing houses, and in processing plants that distributed products over great distances.

Several factors have been identified to contribute to this trend20. Consumer preference has shifted away from thermally processed food products (e.g. canned or blanched/frozen) toward novel, minimally-processed, fresh tasting products such as cut fruits and vegetables, salad mixes, ready-to-eat deli products, and un-pasteurized beverages, which have sensory attributes similar to their fresh counterparts. Consumers may therefore be exposed to an elevated risk of illness from such products until new technologies for making them safe are developed. Manufacturers have expanded their global supply chain for foods and food ingredients to an extent where it can be difficult to assure that best practices for safe growing, packing, and processing of foods are followed. Advances in food microbiology and public health have led to discoveries of previously unknown threats to human health, such as highly virulent strains of bacteria and naturally occurring allergenic compounds that can cause severe illness or even death. At the same time, the number of individuals whose immune systems are impaired during recovery from medical treatments has increased.

Foodborne illness also has significant economic costs. In a survey of U.S. food companies that issued a food recall between 2006 and 2011, 77% reported financial losses of at least $30 million, with 23% stating that costs were even higher17. In 2015, it was estimated that medical costs, legal settlements, income, and productivity losses from plant closures accounted for an annual economic burden of over $15.5 billion18. It is, therefore, not unexpected that the increasing number of food related recalls, illnesses, and outbreaks have caused wholesale buyers to demand proof of compliance with new food safety standards and government regulators to issue food laws and regulations that raise the standards for safe food production and processing practices.

The Risk-Based Approach to Food Safety and the HACCP Concept

Great strides were taken in the twentieth century to assure the safety of the U.S. food system. A series of federal food safety laws culminated with the passage of the Federal Food, Drug, and Cosmetics Act (FD&C) in 1938 [P.L. 75-717]. Among the provisions of the Act, the U.S. Food and Drug Administration (FDA) was given the authority to investigate illnesses or outbreaks attributed to manufactured foods and to inspect food processing facilities and warehouses for compliance with federal food safety standards. Periodic visits by government sanitarians and end-point product testing were thereafter relied upon for assurances of the safety of food products. If someone became ill from eating a food product or if contamination was found during an inspection, the usual practice was for the government to request that the food company destroy or recall the product. However, over time it became clear to many that the existing resources available for on-site inspections were not adequate to oversee a growing and continually changing food industry. A new approach was needed that placed more responsibility on manufacturers to identify potential food safety hazards for their unique products and processes, develop ways to prevent them from occurring before they become a problem, and to document that all practices and policies are consistently implemented.

The Hazard Analysis Critical Control Point (HACCP) food safety management system has emerged as a better alternative to the inspect and test approach and is now the globally accepted system for assuring buyers, the public, and regulators that they have taken all possible measures to reduce or eliminate potential food safety hazards in their operations. HACCP is a systematic and proactive way to consider risks at each step of a manufacturing process and then develop control measures to prevent or reduce food safety risks to acceptable levels.

Risk-based, preventive approaches to food safety began in the 1960s when the National Aeronautics and Space Administration (NASA) adapted "zero defect" engineering and quality assurance systems for assuring the safety of food taken into outer space. These included applications of "Modes of Failure" concepts that require a thorough understanding of the product and the process in order to predict when a food safety "hazard" can occur. In 1985, the National Academy of Sciences (NAS) recommended that HACCP be incorporated into U.S. food regulations. The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) then developed uniform procedures for developing food safety plans known as the seven HACCP principles21.

Worldwide consensus on the utility of HACCP for maintaining the safety of the global food supply was achieved in 2003 when the World Health Organization's (WHO) Codex Alimentarius Committee on Food Hygiene issued Hazard Analysis Critical Control Point guidelines for international trade5. Soon after, the European Union (EU), Canada, Australia, and Japan issued regulations requiring food businesses within their jurisdiction to develop and implement food safety plans based on the NACMCF and Codex HACCP frameworks3.

Over the last three decades, U.S. government agencies have issued a succession of regulations that required HACCP plan development for certain types of foods. In 1995, all U.S. seafood processing facilities were mandated by the Food and Drug Administration (FDA) to develop HACCP plans6. Soon after, the United States Department of Agriculture (USDA) required meat and poultry establishments to write HACCP plans7. In 2001, after a series of food borne illness outbreaks attributed to unpasteurized juice products, FDA directed wholesale juice and cider processors to implement HACCP plans in their operations8.

In the U.S., full adoption of the HACCP approach for assuring the safety of food came in 2011 when Congress passed, and the president signed into law, the Food Safety Modernization Act (FSMA) [P.L. 111-353]. The law is said to be the most sweeping reform of the U.S. food regulatory system since the 1938 FD&C Act was enacted. FSMA adopts the risk-based, preventive approach of HACCP and expands upon it to address potential hazards that have emerged with the development of modern food production and processing practices. The law grants new authority to the U.S. Food and Drug Administration (FDA) to establish and enforce food safety standards encompassing the entire U.S. food system, including farms that grow, harvest, pack, and hold fresh produce; facilities that process, manufacturer, pack, or hold human or animal food; and shippers and receivers involved in transporting human and animal food. The seven regulations issued under FSMA and a brief description of the scope of each are shown in Table 1. Complete information on each regulation can be accessed on the FDA's FSMA website. The FSMA regulation that has the greatest impact on the food processing and manufacturing industry is "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food"9, often abbreviated to simply the "Preventive Controls Rule".