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

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).