Food Safety Law Allows FDA to Proactively Defend Supply Chain

CDC Estimates One in Six Americans Falls Victim to Foodborne Illness Each Year

January 05, 2011 05:35 pm News Staff

Newly enacted food safety legislation will give the FDA the authority it needs to prevent foodborne illness, rather than merely react to outbreaks after they occur, according to HHS Secretary Kathleen Sebelius. The law, known as the FDA Food Safety Modernization Act(, aims to remedy what FDA Commissioner Margaret Hamburg, M.D., last year called "a longstanding gap in FDA's authority."

According to Sebelius, the act is the most significant food safety law promulgated in the past 100 years.

"It will bring our food safety system into the 21st century, improving health, saving lives and helping Americans feel confident that when they sit down at their dinner table, they won't end up in the hospital," Sebelius said during a news conference on Jan. 3, the day before President Obama signed the bill into law.

The legislation includes the following provisions:

  • Food facilities must have a written preventive controls plan that spells out potential safety problems and steps that a company would take to prevent or minimize the likelihood of such problems occurring.
  • The FDA must establish science-based standards for the safe production and harvesting of produce.
  • The agency is directed to increase the frequency of inspections domestically and internationally.
  • The FDA is granted authority to mandate product recalls. The law also allows the agency to suspend the registration of a food facility, thereby preventing it from distributing food.

Some 350 outbreaks of foodborne illness occur each year in the United States, said Sebelius, who acknowledged that the FDA's systems have not kept pace with the growth of a complex, global food supply chain.

Given that the United States imports one-sixth of its food from more than 150 countries, the legislation requires the FDA to inspect at least 600 foreign food facilities this year and to double the number of international inspections every year for the next five years. The act also requires importers to verify the safety of food from their suppliers and gives the agency the authority to block imports from facilities or countries that refuse inspection.

Domestic products also will face a higher level of scrutiny. Last year's outbreak of illness attributed to Salmonella Enteritidis(, which led to nearly 2,000 reported cases from May though November, was traced back to eggs from two Iowa farms.

The CDC recently estimated( that one in six Americans -- or 48 million people -- suffers from foodborne illness each year. More than 125,000 people are hospitalized, and more than 3,000 die.

"That's an unacceptable price to pay for contaminations that are mostly preventable," Sebelius said.

Hamburg, who also spoke during the Jan. 3 news conference, said that the total cost of implementing the provisions of the legislation has been estimated at $1.4 billion during a five-year period, and she acknowledged that Congress still must provide funding. However, Hamburg said she was optimistic that Congress and industry partners would give the agency the resources it needs to overhaul the nation's food safety systems.

Final congressional approval of the bill, which gained House approval in mid-2009 but languished for more than a year in the Senate, coincided with yet another foodborne illness outbreak( Between Nov. 1 and Dec. 27 of last year, more than 90 cases of salmonellosis in 16 states and the District of Columbia were linked to alfalfa sprouts sourced by Jimmy John's restaurants from a company in Urbana, Ill.

According to a CDC report( published in the January issue of the journal Emerging Infectious Diseases, an estimated 9.4 million episodes of foodborne illness in the United States each year -- only a fraction of the total illnesses reported -- can be attributed to 31 known domestically acquired pathogens. The study used data drawn primarily from 2000-08, and all estimates were based on the 2006 U.S. population level of 299 million people.

Of this subset of cases, researchers found that most illnesses were caused by norovirus (58 percent), followed by nontyphoidal Salmonella spp. (11 percent), Clostridium perfringens (10 percent), and Campylobacter spp. (9 percent). Leading causes of hospitalization were nontyphoidal Salmonella spp. (35 percent), norovirus (26 percent), Campylobacter spp. (15 percent), and Toxoplasma gondii (8 percent). Leading causes of death were nontyphoidal Salmonella spp. (28 percent), T. gondii (24 percent), Listeria monocytogenes (19 percent), and norovirus (11 percent).

Chris Braden, M.D., acting director of the CDC's Division of Foodborne, Waterborne and Environmental Diseases, commented on the study during a Dec. 15 news conference(

"Though we have seen clear progress in the past 10 years, these numbers illustrate a very real impact of foodborne illnesses in the United States," Braden said. "It affects tens of millions of Americans each year. It remains a substantial public health problem."

If the annual incidence of foodborne illness was reduced by just 1 percent, he noted, about 500,000 fewer Americans would get sick each year.

Physicians can direct patients with food safety questions or concerns to The federal website, a combined effort of the CDC, the FDA and the U.S. Department of Agriculture, offers consumers tips about proper methods of cleaning, handling, preparing and storing food, as well as information about product recalls.