Confront safety issues by managing and controlling product hazards.

You have probably read the headlines: “Executives sentenced to several years of jail time after distributing product known to be contaminated with Salmonella,” “Oldest frozen hamburger manufacturer closes its doors after recalling one year’s worth of product with E. coli contamination,” “33 deaths and 125 illnesses attributed to Listeria in cantaloupe,” and “Over 150 brands of pet food recalled due to melamine contamination.”

Food and feed safety issues can have dire consequences for companies, the food supply chain and ultimately the consumer. Prerequisite programs play a critical role in confronting possible food safety issues because they help companies manage and control product hazards.

Foodborne illness can be deadly

According to the Centers for Disease Control and Prevention, 1 in 6 people get sick with foodborne illnesses each year in the U.S. alone.1 That’s 48 million illnesses, including 128,000 hospitalizations and 3,000 fatalities.1

In 2014 there were 562 recalls issued by the Food and Drug Administration (FDA). 184 of those were for undeclared allergens, while most of the remaining 378 were due to microbiological pathogens and a few resulting from foreign material or pesticides.2,3 150 products regulated by the U.S. Department of Agriculture (USDA) were recalled in 2015, accounting for over 21 million pounds of recalled product.4

Food contamination costs U.S. health authorities $15.6 billion per year.5 Half of all food recalls cost the affected companies more than $10 million.5

U.S. food safety systems are regulated

The U.S. has one of the most, if not the most, robust food and feed safety systems in the world. Companies that produce, manufacture and distribute food and feed products are regulated by federal agencies such as the FDA and USDA, as well as state agencies. Food and feed safety laws have been in place for decades and continue to improve with new information about product hazards and better systems of identifying and mitigating those hazards.

Some of the most significant directives include the Food, Drug and Cosmetic Act (FD&C), Current Good Manufacturing Practices (CGMPs) and regulations for meat, poultry and processed egg products. The Food Safety Modernization Act (FSMA) is the most recent addition — signed into law in 2011 — and is the most sweeping change to food safety since the FD&C Act was enacted in 1938.6FSMA shifts the focus from responding to food contamination to preventing it, requiring more of food and feed companies and giving the FDA additional authority to regulate both domestic and foreign companies.

Hazard Analysis and Critical Control Point (HACCP)

Many companies develop programs and systems as part of their overall Food or Feed Safety Plan to manage potential product hazards. One of the higher level programs for most companies is their HACCP program.

HACCP was originally developed in 1959 by Dr. Howard Bauman of the Pillsbury Company.7 Dr. Bauman was tasked to provide NASA with food that was 100% safe.7 He recognized the only way to do this was to establish control over the entire process: raw materials, surfaces, people and the environment.7

Today HACCP is recognized around the world and by the World Health Organization as a system that identifies, evaluates and controls significant food safety hazards. However, prerequisite programs must be established and effective in order for HACCP to function properly.

The Good Manufacturing Practices (GMPs)

The GMPs published by the FDA in the 1960s are considered by many to be the original outline for prerequisite programs.8 There have been several updates to the GMPs and they are now known as the Current Good Manufacturing Practices (CGMPs).8

The CGMPs guide companies in the safe production of food and feed products and set the expectation for FDA requirements. The CGMPs cover areas such as plant and grounds, general maintenance, sanitary facilities and control, equipment and utensils, production and process controls and personnel.

The CGMPs set the expectation of what should be done, but allow companies to decide how to best manage those requirements. Food and feed companies have developed prerequisite programs in order to address how to manage CGMP requirements. The number and complexity of prerequisite programs depends on the product and whether they are regulated HACCP by the FDA or USDA. Regulated HACCP includes meat, seafood and juice products.

The Preventive Controls Rules

FSMA added a twist to the prerequisite programs — The Preventive Controls Rules issued by the FDA in September 2015 for both human and animal feed added new preventive controls provisions.

Prerequisite programs and preventive controls can be the same, but preventive controls is a regulatory term within FSMA. The FDA has established specific requirements for the preventive controls necessary to address known or reasonably foreseeable hazards.

Monitoring, corrective action, verification (including validation and reanalysis) and associated records will be required when preventive controls are necessary.

Within FSMA, not all preventive controls will require corrective action procedures specific to each preventive control and not all preventive controls such as food allergen controls, sanitation controls, supply-chain program and recall plans will require validation.

Importance of prerequisite programs and preventive controls

Prerequisite programs and preventive controls are the foundation that HACCP programs are built around and are required by FSMA. Food and feed safety issues, including recalls, are generally not linked to the failure of a HACCP Critical Control Point, but are typically associated with the failure of a prerequisite program. This is why the FDA chooses to not require HACCP programs for all companies and products. Instead, they focus on the fact that preventive controls are necessary to manage hazards and that employees should be trained and knowledgeable in these programs and controls.

Prerequisite programs are a critical tool to help companies manage their food and feed safety plans. In doing so, they help protect the public and your company from contamination, recalls and other hazards.

Check out our articles on specific prerequisite programs to get a better understanding of what they are and how to develop, implement and manage them.


[1] "Foodborne germs and illnesses." Centers for Disease Control and Prevention. December 21, 2015.
[2] Pinneo, Sarah. “Food Recalls: What You Need to Know to Stay Safe.” Safe Bee. March 30, 2015.
[3] “2014 Recalls, Market Withdrawals & Safety Alerts.” U.S. Food and Drug Administration. May 13, 2016.
[4] “Summary of Recall Cases in Calendar Year 2015.” USDA Food Safety Inspection Service. March 16, 2016.
[5] Knüsli, Daniel, Friedli, Roland, and Jürg Busenhart. "Food Safety in a Globalised World." Swiss Re, 2015.
[6] “FDA Food Safety Modernization Act (FSMA).” U.S. Food and Drug Administration. May 6, 2016.
[7] Stier, Richard and William Sperber. “Happy 50th Birthday to HAACP: Retrospective and Prospective.” Food Safety Magazine. December 2009/January 2010.
[8] “GMPs – Section One: Current Food Good Manufacturing Practices.” U.S. Food and Drug Administration. August 9, 2004.

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