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U.S. Department of Health and Human Services

Animal & Veterinary

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Historic Changes to the Food Safety System

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by Kelly Roy, Center for Veterinary Medicine, FDA

The FDA Food Safety Modernization Act (FSMA) is the first large-scale overhaul of FDA’s food safety system since the Food, Drug, and Cosmetic Act was passed in 1938. FSMA, signed into law by President Obama on January 4, 2011, focuses on prevention and risk-based analysis.

Based on recent data from the Centers for Disease Control and Prevention, an estimated one in six Americans experience foodborne illness each year. In recent years, there have been high-profile foodborne illness outbreaks related to various foods, including spinach, peanuts, and eggs. There have also been large scale food recalls, including the melamine recall of 2007 that affected more than 100 brands of pet food. Events such as these have emphasized the need for continuous improvements to food safety in the U.S. The Food, Drug, and Cosmetic Act of 1938 focused on reacting to problems in the marketplace. FSMA, on the other hand, incorporates a proactive approach to food safety, addressing hazards from farm to table or from farm to dog bowl, whichever the case may be.

“This law helps us take the critical steps toward strengthening the food safety system that is vital to the health and security of the American people.” - Margaret A. Hamburg, MD, Commissioner of Food and Drugs

There are four main themes at the heart of the legislation:

  • Prevention;
  • Responsibility and accountability through inspections, compliance, and response to outbreaks;
  • Safety of imported foods; and
  • Enhanced partnerships.


FDA holds firms accountable for creating a written food safety plan, monitoring their systems, fixing problems when they occur, and maintaining records of all preventive measures taken. FDA will issue regulations to prevent intentional contamination of the food supply and establish science-based strategies to protect the food supply chain. Prevention standards will take into account natural hazards and hazards resulting from intentional tampering.

Inspections, Compliance, and Response

To ensure that firms are meeting their prevention responsibilities, FSMA includes an inspection mandate, and while inspection frequency increases, FDA is considering new ways to incorporate a risk-based approach to these inspections. The legislation enables FDA to issue mandatory recalls when a firm fails to voluntarily recall unsafe food. In addition, the law provides a flexible standard for administrative detention (the procedure FDA uses to keep suspect food from being moved) and allows FDA to suspend a food facility’s registration, thereby preventing the firm from distributing unsafe food. The law also directs the agency to improve its ability to track both domestic and imported foods.

Import Safety

Today, fifteen percent of the U.S. food supply is imported. The new law includes additional requirements for importers, to better ensure that food entering the country is as safe as the food produced in the U.S. Importers will be responsible for ensuring that foreign firms have adequate preventive controls in place. FDA can also now require mandatory certification of high-risk foods, and can deny entry of a product if access for a facility inspection has been denied.

Enhanced Partnerships

By passing FSMA, lawmakers recognized that, to achieve the public health goals of the U.S., all food safety agencies need to work together. FDA is authorized by the new food safety law to rely on other federal, state, local, and foreign food safety agencies to meet the mandated inspection frequency of domestic and foreign facilities. FDA is required to develop and implement strategies that will leverage and enhance the food safety and defense capacities of state and local agencies. Additional partnerships are required to improve foodborne illness surveillance, develop a national agriculture and food defense strategy, and build an integrated network of laboratories to meet the food safety goals of the new law.

FDA has already begun to implement FSMA. The law will require 50 new rules, guidance documents, and several reports within three years. Input from industry and consumer stakeholders will be used in the early stages of implementing FSMA, and FDA will continue to solicit input and seek assistance. FDA experts from the Center for Veterinary Medicine, the Center for Food Safety and Applied Nutrition, and other officials working with FDA’s Office of Foods will be dedicating extensive time and effort to bringing about these historic changes.

FDA Deputy Commissioner for Foods, Michael R. Taylor, JD, who has been in the forefront of FDA’s efforts to have FSMA signed into law said, “This moment has been a long time coming – a moment when we’re no longer talking about the need for food safety legislation, but rather how we’re going to implement it.”