FDA given more authority over recalls, records, imports

Published on February 15, 2011
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A law passed in early January gives federal regulators more authority over food production, including the ability to force recalls of foods that risk human or animal health.

The FDA Food Safety Modernization Act, which modifies the federal Food, Drug, and Cosmetic Act, was signed into law by President Barack Obama on Jan. 4. The legislation also gives the FDA authority to see more records from food producers during investigations, to suspend registrations that allow facilities to produce or distribute food, to start pilot projects connected with identifying recipients and origins of food items, to hire more than 2,000 total additional field staff in fiscal years 2011 through 2014, to initiate competitive grant programs connected with food safety, to require additional certification or assurance from food importers, to refuse importation of food from facilities that turn away U.S. inspectors, and to establish FDA offices in foreign countries.

Food producers will also have to analyze and write reports about hazards in their facilities and give the FDA results of laboratory tests performed on food items on behalf of producers or consignees. The legislation also offers protections for people who work for food makers and tell state or federal authorities about employers' violations, testify about such violations, or refuse to participate in illegal activities.

The new law is also intended to increase the number of FDA inspections of all food producers, but the agency will consider the type of food produced, compliance history, and producers' hazard analysis and controls in considering the frequency of visits.

The AVMA supported the bill, which is seen as consistent with the AVMA Food Safety Policy.

The Centers for Disease Control and Prevention published in the January issue of Emerging Infectious Diseases two reports that together indicate tainted or contaminated food accounts for about 48 million illnesses annually, including about 3,000 deaths.

Sen. Richard J. Durbin of Illinois, who introduced the original bill, said in an announcement that the FDA had been hampered by outdated laws, inadequate staff, and insufficient funding. He cited recalls of peanut butter contaminated with Salmonella organisms, spinach with Escherichia coli, and chili with botulinum toxin as examples of harm caused by an outdated food safety system. The bill that became law contained similar language, but it originated in the House of Representatives.

Kathleen Sebelius, secretary of Health and Human Services, said in a conference call with news media that the "long overdue" act was the most substantial food safety law of the past 100 years. She expressed confidence that the updates would improve health, save lives, and increase confidence in food safety. She noted that the FDA will have the power to make sure facilities connected with the food supply adopt policies to reduce contamination, and the law will help the FDA ensure the safety of imported food, which she said accounts for one-sixth of the nation's food and 80 percent of the seafood.

Margaret A. Hamburg, MD, commissioner of Food and Drugs, said in the conference call that the Congressional Budget Office estimates that implementing the legislation will cost about $1.4 billion over five years.