Health, Safety, Security and Environment

E-Books: Hazard Analysis and Risk-Based Preventive Controls Improving Food Safety in Human Food Manufacturing for Food Businesses

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The goal of this book is to help demystify the FDA’s Preventive Controls for Human Foods (PCHF) regulations for retail food sales and service business professionals. Hazard analysis and risk-based preventive controls also represent invaluable tools to the retail food business to ensure food safety in their supply chain. Therefore, it is also our goal to help the retail food businesses, who purchase, prepare, and sell manufactured foods and ingredients to the consumer, use hazard analysis and risk-based preventive control processes as specifications for their suppliers to enhance the oversight of food safety in their supply chain.

When we began research for this book, we identified a variety of resources that detailed how a food manufacturing business could perform a hazard analysis and develop risk-based preventive controls. These resources included the Food Safety Modernization Act (FSMA) regulations themselves, official industry comments (and FDA responses) to the proposed rules, other FDA information sources (FAQs, webinars, presentations), and guidance documents (some of which are still in draft form at the time of this publication). We both believed that another perspective on the prevention of foodborne disease outbreaks would be useful: that of retail food sales and service business professionals tasked with sourcing safe ingredients and food products from (and in collaboration with) manufacturers.

It is important to remember that this book is not a “how-to” guide on complying with FSMA’s PCHF regulations nor is it a blueprint for following other rules established under FSMA. Indeed, during our research for this book, we found that the FDA and its collaborators have already done a tremendous job in preparing the industry for PCHF through the Food Safety Preventive Controls Alliance (FSPCA).

The FSPCA is a public-private alliance made up of industry, academic, and government stakeholders tasked with developing training programs and material to educate industry and others on PCHF (and other foundational rules of FSMA).


The FSPCA’s mission is “to support safe food production by developing a nationwide core curriculum, training, and outreach programs to help companies that produce human and animal food in complying with the preventive controls regulations that are part of the Food Safety Modernization Act (FSMA)” (Food Safety Preventive Controls Alliance, 2016a).

The FSPCA training materials provide ample resources and tools, including easy-to-use templates to document the hazard analysis and risk-based preventive control requirements within a Food Safety Plan (Food Safety Preventive Controls Alliance, 2016b).

Before you begin reading this book, let us get on the same page on the difference between controlling food safety risk and preventing food safety hazards. A food safety hazard is something that can cause serious illness, injury, or death when found in foods. In the retail food business where consumers may be impacted, a foodborne illness can be a risk to a consumer based on the likelihood of a hazard occurring in a food, the probability of the hazard causing illness or injury to that individual, and the severity of the illness or injury to the individual. The risk of illness is best avoided by focusing on and preventing the hazard.

If a single hazard in food could cause death (e.g., an undeclared allergen consumed by a severely allergic individual), but there is very little probability that the hazard can get into the food due to rigorous preventive controls, then the risk is very low (Table 1.1). However, if a preventive control that manages that hazard is removed, the risk may be high.

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