16. May 2011
In January of 2011, the Food Safety Modernization Act (Act) was signed into law by President Obama. The Act is considered to be the most significant update to food safety laws since the Federal Food, Drug and Cosmetic Act of 1938.
The legislation directs the Food and Drug Administration (“FDA”) to create a new framework for food safety oversight that is even more focused on the prevention of problems that can cause food-borne illness.
The Act provides the FDA with more effective enforcement tools, mandates new inspections of food processing facilities and allows the FDA greater ability to control food products being imported into the United States.
Several parts of the Act caused immediate changes that regulated facilities should be aware of:
The FDA now has additional records access when a “reasonable probability” of “serious adverse health consequences” exists
The FDA now holds mandatory recall authority for food that is adulterated or misbranded, or food that may have serious adverse health consequences
The FDA will immediately increase facility inspection frequency. Finally, the Act provides new whistleblower protections to protect employees that report violations or are involved in violation proceedings.
On May 4, 2011, the FDA issued its first new rules under the Act. Both of the rules are scheduled to take effect on July 3, 2011.
The first rule allows the FDA to “administratively detain” food that is believed to have been produced under “insanitary or unsafe conditions.” Prior to the passage of the Act, the FDA could only detain those items when evidence suggested that a food product was contaminated or mislabeled and would present a “threat of serious adverse health consequences or death to humans or animals.” The rule will allow the FDA to detain products for up to 30 days to ensure that the products will not enter the marketplace.
The second rule requires importers of food into the United States to report to the FDA if their products were refused entry into any other country. This will provide additional information about products, including food for animals, that may pose a significant risk to public health. Information about previously refused products will allow the FDA to “mobilize and assist in the detention and removal of products” that may be harmful.
The Food Safety Modernization Act and the subsequent rules are all a part of the FDA’s approach to implementing new food safety laws.