FDA Moves to Implement Food Safety Modernization Act

11 Sep 2015 --- The U.S. Food and Drug Administration (FDA) has taken one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

The action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Dr. Stephen Ostroff, acting FDA commissioner.

The two rules finalized today, the preventive controls rules, focus on implementing modern food manufacturing processes for both human and animal foods. Today’s announcement will ensure that food companies are taking action and working with the FDA to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

The preventive controls rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring. This means that food companies will be accountable for monitoring their facilities and identifying any potential hazards in their products and prevent those hazards.  Under these rules, the FDA will be able to assess these systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food. 

The preventive controls final rules announced today are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”

Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

CSPI Senior Food Safety Attorney David Plunkett stated: “Under the preventive controls rules released today by the Food and Drug Administration, food manufacturers must develop food safety plans for how they will mitigate or prevent contamination during processing. Also, FDA inspectors will have access to more information about conditions in the food facility. This will help them ensure that companies are complying with their food safety plans. CSPI is disappointed, however, that the FDA exempted thousands of companies that Congress intended to be covered by the new requirements.”

“It has been a long slow slog, but our country has now taken a major step toward creating a truly modern food safety system, and that’s good news for consumers. This transformative rule focuses on preventing illnesses rather than just responding after people are already sick. Now Congress must fund FDA so that it could actually conduct inspections and help industry comply with the new requirements.”

Pamela G. Bailey, president and CEO of The Grocery Manufacturers Association (GMA) stated: “We welcome the final FSMA rules for preventative controls for human and animal food and commend FDA for the deliberative and inclusive approach it took in developing these regulations.”

“FSMA ensures that prevention is the cornerstone of our nation’s food safety strategy, places new responsibilities on food and beverage manufacturers, and provides the FDA with the authorities it needs to further strengthen our nation’s food safety net.”

“GMA is proud of its work to support FSMA and has taken a leadership role on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, in the U.S. and along the entire global supply chain.  We look forward to continuing those education efforts in the months ahead.”

“FSMA represents a comprehensive system of preventative measures so it is essential that FDA be appropriately resourcedto effectively implement and enforce all of the food safety mandates set forth in the law.  The food and beverage industry is committed to working with Congress, the Obama Administration and all stakeholders to ensure that Congress appropriates the necessary funding for FDA to fully implement FSMA.”